Visian ICL (Implantable Collamer Lens)Recalls & reported problems across all models
Staar Surgical Company · 96 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 919
- Deaths reported
- 0
- Injuries reported
- 550
- Recalls
- 0
We found 96 models of Visian ICL (Implantable Collamer Lens) by Staar Surgical Company in the FDA's device registry (GUDID). Together they are named in 919 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2015 and Feb 12, 2025 — classified as 550 injuries, 369 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (399 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 ICL (Implantable Collamer Lens) problems
Device problems
- Inadequacy of Device Shape and/or Size399
- Device Operates Differently Than Expected135
- No Apparent Adverse Event126
- Adverse Event Without Identified Device or Use Problem112
- Unintended Movement47
- Misfocusing44
- Optical Problem41
- Appropriate Device Problem Term/Code Not Available34
Patient problems
- No Code Available363
- Intraocular Pressure Increased174
- No Clinical Signs, Symptoms or Conditions159
- No Known Impact Or Consequence To Patient143
- No Consequences Or Impact To Patient105
- Blurred Vision82
- No Patient Involvement62
- Visual Disturbances59
Visian ICL (Implantable Collamer Lens) models
96 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic32 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic31 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic29 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic28 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic27 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic26 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic26 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic26 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic25 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic25 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic24 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic22 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic22 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic22 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic20 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic19 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic19 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic19 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic19 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic18 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic17 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic17 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic14 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic14 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic13 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic12 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic12 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic12 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic12 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic12 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic11 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic11 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic11 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic11 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic10 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic10 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic9 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic9 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic9 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic9 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic8 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic8 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic8 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic8 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic8 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic8 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic7 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic6 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic6 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic6 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic6 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic6 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic5 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic5 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic5 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic5 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic5 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic5 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic4 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic4 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic4 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic4 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic4 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic4 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic3 reports
- Visian ICL (Implantable Collamer Lens) MCL 12.1Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.2Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic2 reports
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.1Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 12.6Lens, Intraocular, Phakic1 report
- Visian ICL (Implantable Collamer Lens) MICL 13.7Lens, Intraocular, Phakic1 report
Recent Visian ICL (Implantable Collamer Lens) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE CHANGE OVERT TIME, INTERMITTENT ANGLE CLOSURE WITH ELEVATED IOP. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS REPORT 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. IT SHOULD BE NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT SUGGESTED BY THE ICL SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED AS PART OF THE NORMAL DSC MEETINGS AND CAPA MONITORING. IF A SIGNIFICANT TREND IS IDENTIFIED, THEN THE ISSUE WILL BE ESCALATED FOR FURTHER ACTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 21370038 ↗InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE CHANGE OVERT TIME, INTERMITTENT ANGLE CLOSURE WITH ELEVATED IOP. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS REPORT 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. IT SHOULD BE NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT SUGGESTED BY THE ICL SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED AS PART OF THE NORMAL DSC MEETINGS AND CAPA MONITORING. IF A SIGNIFICANT TREND IS IDENTIFIED, THEN THE ISSUE WILL BE ESCALATED FOR FURTHER ACTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 21369526 ↗InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS OPACITY (ASYMPTOMATIC CATARACT) . LENS REMAINS IMPLANTED. PROBLEM WAS NOT RESOLVED. STATUS OF EYE IS ASYMPTOMATIC. CAUSE OF EVENT IS REPORTED AS UNKNOWN.
Patient problems: Cataract
MAUDE report 19706406 ↗InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Optical Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Optical Problem; Unintended Movement
THE REPORTER INDICATED THAT 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS OF A -10.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2024, THE LENS WAS REMOVED AND A LONGER LENGTH LENS WAS IMPLANTED DUE TO LENS DISLOCATION/SUBLUXATION, GLARE/HALOES, AND DECENTRATION OF LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. STATUS OF THE EYE IS REPORTED AS "HEALTHY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances
MAUDE report 18673586 ↗InjuryAug 14, 2023Misfocusing; Misfocusing
THE REPORTER INDICATED THAT A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS OF -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO REFRACTIVE SURPRISE AND LENS OPACITY. IT WAS REPORTED THAT REFRACTIVE TREATMENT AND PHACO-EMULSIFICATION WITH IOL IMPLANTATION WAS PERFORMED AND THE PROBLEM RESOLVED. THE REPORTER STATES THAT THE DEVICE FAILED TO PERFORM AS INTENDED, FOR CAUSE DETAILS THE REPORTER STATED " THE REFRACTIVE SURPRISE RESULTED IN A HYPEROPIC LVC (LASER VISION CORRECTION) AND UNSATISFACTORY VISION. THE ASC WAS OF LESSER ISSUE".
Patient problems: Blurred Vision; Cataract
MAUDE report 17547267 ↗InjuryMay 24, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -09.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. A CATARACT WAS OBSERVED AND THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Cataract
MAUDE report 16998309 ↗InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL3.2 IMPLANTABLE COLLAMER LENS, -08.00 DIOPTER, INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS REMOVED ON (B)(6) 2023. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16595118 ↗InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS REMOVED ON (B)(6) 2023. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16595091 ↗InjuryNov 30, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. NARROW VAULT AND PATIENT NEEDED CE (CATARACT EXTRACTION) OD DUE TO CONTACT WITH ICL. FORMING CATARACT. 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: Cataract
MAUDE report 15891259 ↗InjuryNov 30, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS OF -3.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. NARROW VAULT 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 15891065 ↗InjuryNov 22, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6; -14.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE SURGEON REPORTS LENS OPACITY OF ASC AND PSC WHICH WAS OBSERVED ON (B)(6) 2021. ON (B)(6) 2022 THE LENS WAS EXPLANTED AND PHACO-EMULSIFICATION AND IOL IMPLANTATION WAS PERFORMED. THE PROBLEM AS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND NOTED "PATIENT REPORTED BEING HIT HARD IN THE LEFT EYE AND HER VISION BEGAN TO BLUR/GET HAZY".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cataract
MAUDE report 15848263 ↗InjuryNov 11, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -06.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS REPORTED AS REFRACTIVE CHANGE OVERTIME AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15784668 ↗InjuryNov 11, 2022Misfocusing; Misfocusing
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE AND BLURRED VISION. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Blurred Vision
MAUDE report 15784581 ↗InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM MICL13.7; -15.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT LEFT (OS) ON (B)(6) 2021. THE SURGEON REPORTS THE PATIENT HAS DEVELOPED POSTERIOR CAPSULAR CATARACTS. 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: Cataract
MAUDE report 15621428 ↗InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM MICL13.7; -15.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE SURGEON REPORTS THE PATIENT HAS DEVELOPED POSTERIOR CAPSULAR CATARACTS. 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: Cataract
MAUDE report 15621351 ↗
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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