Visian Toric ICL (Implantable Collamer Lens for Myopia)Recalls & reported problems across all models
Staar Surgical Company · 293 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 532
- Deaths reported
- 0
- Injuries reported
- 380
- Recalls
- 0
We found 293 models of Visian Toric ICL (Implantable Collamer Lens for Myopia) by Staar Surgical Company in the FDA's device registry (GUDID). Together they are named in 532 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2018 and Jan 29, 2026 — classified as 380 injuries, 152 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (220 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Visian Toric ICL (Implantable Collamer Lens for Myopia) problems
Device problems
- Inadequacy of Device Shape and/or Size220
- No Apparent Adverse Event104
- Device Dislodged or Dislocated89
- Adverse Event Without Identified Device or Use Problem86
- Misfocusing70
- Off-Label Use41
- Optical Problem27
- Unintended Movement27
Patient problems
- No Clinical Signs, Symptoms or Conditions209
- No Code Available110
- Intraocular Pressure Increased102
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available83
- Blurred Vision78
- Visual Disturbances36
- No Known Impact Or Consequence To Patient35
- Cataract23
Visian Toric ICL (Implantable Collamer Lens for Myopia) models
293 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.0/1.0)Phakic Toric Intraocular Lens7 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.0/1.0)Phakic Toric Intraocular Lens7 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.0/1.5)Phakic Toric Intraocular Lens6 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.5/1.0)Phakic Toric Intraocular Lens6 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-6.5/2.5)Phakic Toric Intraocular Lens5 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/1.5)Phakic Toric Intraocular Lens5 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-8.0/1.0)Phakic Toric Intraocular Lens5 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-9.5/1.0)Phakic Toric Intraocular Lens5 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.5/1.0)Phakic Toric Intraocular Lens5 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.5/1.5)Phakic Toric Intraocular Lens5 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.5/1.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.0/1.5)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.5/1.5)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.0/2.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/1.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/1.5)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-7.5/1.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.0/1.5)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.0/2.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.5/1.5)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.5/1.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.5/2.5)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-14.0/1.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-16.0/2.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-16.0/3.0)Phakic Toric Intraocular Lens4 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-16.0/3.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-7.0/4.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-8.5/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-8.5/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.0/2.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.0/3.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.5/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.0/3.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.5/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.5/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.5/3.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.5/2.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.5/3.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.5/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.5/4.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-16.0/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-16.5/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-5.5/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-5.5/2.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-7.5/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-8.5/2.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-9.0/3.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-9.5/2.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.5/2.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.5/2.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.0/2.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.0/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.0/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.0/2.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.5/2.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.0/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-14.0/3.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-14.5/2.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-15.0/1.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-15.5/1.5)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-15.5/3.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.7 (-12.0/2.0)Phakic Toric Intraocular Lens3 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-8.5/4.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-9.0/1.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-9.0/3.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-10.0/3.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-12.5/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-13.5/1.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-16.0/4.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-5.0/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-5.5/1.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-6.0/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-6.5/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-7.0/1.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-7.0/2.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-8.0/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.0/1.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.5/1.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.5/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.0/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.0/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.0/3.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.5/2.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.5/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.5/2.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/2.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/3.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/4.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.5/1.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.0/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.0/3.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.5/2.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/4.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.5/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-15.0/2.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-15.0/2.5)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-15.5/3.0)Phakic Toric Intraocular Lens2 reports
- Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-16.0/3.5)Phakic Toric Intraocular Lens2 reports
Recent Visian Toric ICL (Implantable Collamer Lens for Myopia) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A CATARACT. THE LENS WAS EXPLANTED AND CATARACT SURGERY WAS PERFORMED. CAUSE OF THE EVENT IS UNKNOWN.
Patient problems: Cataract
MAUDE report 24216310 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION. IN A SEPARATE VISIT THE LENS THE LENS WAS REPOSITIONED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155737 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION. IN A SEPARATE VISIT THE LENS THE LENS WAS REPOSITIONED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155736 ↗InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE. RESIDUAL REFRACTIVE ERROR WAS REPORTED BY THE SURGEON. LASIK SURGERY WAS PERFORMED AND THE PROBLEM RESOLVED. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER, "UNRELATED TO DEVICE BUT RELATED TO PROCEDURE."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 21300834 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL ASTIGMATISM. IN A SEPARATE VISIT PRK WAS PERFORMED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER, AND THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "SURGEON REPORTS UNRELATED TO DEVICE BUT RELATED TO PROCEDURE".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Cataract; Halo; Visual Disturbances
MAUDE report 21154297 ↗MalfunctionAug 20, 2024No Apparent Adverse Event; No Apparent Adverse Event
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION. THE LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20007277 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 12.1MM, TMICL12.1, -16.0/3.5/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED. THE LENS WAS REPOSITIONED ON (B)(6) 2024. THIS DID NOT RESOLVE THE PROBLEM. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19613816 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 12.1MM, TMICL12.1, -16.0/3.5/090 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED. THE LENS WAS REPOSITIONED ON (B)(6) 2021. THIS DID NOT RESOLVE THE PROBLEM. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED ASPATIENT RELATED FACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19613789 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE REPORTER INDICATED THAT 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF A -11.0/3.0/088 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. LOW VAULT WITH VERY MILD CATARACT WAS REPORTED. A LENS EXCHANGE IS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19323185 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE REPORTER INDICATED THAT 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF A -10.5/1.5/076 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. LOW VAULT WITH VERY MILD CATARACT WAS REPORTED. A LENS EXCHANGE IS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19323063 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 -5.0/2.5/091 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. REFRACTIVE CHANGE OVER TIME WAS OBSERVED. LENS WAS REPOSITIONED ON (B)(6) 2021 WHICH RESOLVED THE PROBLEM. ON (B)(6) 2024, STATUS OF EYE WAS REPORTED AS "LENS OFF AXIS" AND PROBLEM NOT RESOLVED. PLAN TO EXCHANGE FOR A LONGER LENS. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19215260 ↗MalfunctionDec 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE REPORTER INDICATED THAT A 13.2MM TMICL 13.2 IMPLANTABLE COLLAMER LENS OF -15.50/1.5/154 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS EYE. LENS ROTATION WAS OBSERVED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18384213 ↗InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -10.50/1.5/137 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS REPORTED THAT THE LENS ROTATED IN THE EYE AND WAS THE WRONG SIZE. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18188682 ↗MalfunctionNov 6, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF -10.00/2.5/107 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). A SCHEDULED LENS REMOVAL FOR AN UNKNOWN REASON WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081125 ↗MalfunctionNov 6, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF -9.50/2.5/065 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). A SCHEDULED LENS REMOVAL FOR AN UNKNOWN REASON WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081083 ↗
Other Staar Surgical Company products
All Staar Surgical Company devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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