MultiflexRecalls & reported problems across all models
Alcon Laboratories, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 28 models of Multiflex by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2021 and Sep 21, 2026 — classified as 21 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 Multiflex problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Break10
- Device Dislodged or Dislocated9
- Defective Device4
- Malposition of Device3
- Material Twisted/Bent3
- Material Split, Cut or Torn2
- Scratched Material2
Patient problems
- Insufficient Information19
- No Clinical Signs, Symptoms or Conditions11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Capsular Bag Tear3
- Visual Impairment3
- Blurred Vision2
- Inflammation2
- Intraocular Pressure Increased2
Multiflex models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Multiflex MTA3U0intraocular lens4 reports
- Multiflex MTA4U0intraocular lens4 reports
- Multiflex MTA3U0intraocular lens3 reports
- Multiflex MTA4U0intraocular lens3 reports
- Multiflex MTA4U0intraocular lens3 reports
- Multiflex MTA3U0intraocular lens2 reports
- Multiflex MTA3U0intraocular lens2 reports
- Multiflex MTA3U0intraocular lens2 reports
- Multiflex MTA3U0intraocular lens2 reports
- Multiflex MTA3U0intraocular lens2 reports
- Multiflex MTA4U0intraocular lens2 reports
- Multiflex MTA4U0intraocular lens2 reports
- Multiflex MTA3U0intraocular lens1 report
- Multiflex MTA3U0intraocular lens1 report
- Multiflex MTA3U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
- Multiflex MTA4U0intraocular lens1 report
Recent Multiflex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Scratched Material
A physician reported that during an intraocular lens (IOL) implant procedure, scratch or mark on optic was observed. There was no patient contact. The procedure was completed on the same day.Additional information has been received stating there was no patient harm, scratch was noticed just before insertion into the patient eye.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841403 ↗MalfunctionSep 20, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50834655 ↗MalfunctionSep 15, 2026Material Split, Cut or Torn
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed lens broke half in the patient's eye after the IOL was implanted into the eye. The lens was explanted during initial procedure.Additional information has been requested and received stating that the procedure was completed on same day by using same model and diopter lens.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770936 ↗InjuryMay 15, 2026Device Dislodged or Dislocated
A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL WAS DISLOCATED. THE CLINICAL REASON PROVIDED FOR EXPLANTATION WAS MECHANICAL BREAKDOWN IOL DISLOCATION. NO REPLACEMENT LENS WAS IMPLANTED, AND THE PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25186300 ↗InjuryMay 8, 2026Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT'S VISION WAS POOR AND ACHING PAIN IN EYES. THE LENS WAS EXCHANGED WITH SIMILAR COMPANY LENS MODEL BUT DIFFERENT DIOPTER VALUE AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS POSTERIOR DISLOCATION OF LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 25125706 ↗InjuryApr 24, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXCHANGED AFTER SURGERY DUE TO AN UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24987371 ↗MalfunctionApr 17, 2026Break; Material Twisted/Bent
A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON REALIZED THE HAPTIC WAS BEND AND BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24913039 ↗MalfunctionMar 5, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24518729 ↗MalfunctionDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED DURING PHACOEMULSIFICATION SURGERY WITH ANTERIOR CHAMBER INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL CASING WAS OPENED PRIOR IMPLANT INTO PATIENT'S EYE. SURGEON USED COMPANY OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND GLIDE TO IMPLANT THE IOL. WHEN IOL IN THE EYE, FOUND THE LENS NOT STABLE AND TENDENCY TO DROP. SURGEON DECIDED NOT TO PROCEED WITH IMPLANTATION AND EXPLANTED THE LENS. THE PATIENT¿S EYE LEFT WITH APHAKIA, AND SURGEON CLOSED THE WOUND AND COMPLETED THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23790737 ↗MalfunctionNov 28, 2025Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE FAULTY. ONLY ONE HANDLE/ARM ON LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23672017 ↗InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD POSTERIOR CAPSULE RUPTURE DUE TO WHICH SURGEON CHANGED LENS TO PROVIDE BETTER OUTCOME TO PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 23552893 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED EXPERIENCING UNEXPECTED VISUAL OUTCOMES FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION. SHE STATED THAT THE IOL IN HER LEFT EYE HAD DISLOCATED, THAT'S WHY SHE HAD THIS LENS PLACED AS REPLACEMENT. THE NEW LENS WAS PLACED BEHIND HER CORNEA, IN FRONT OF HER IRIS IN THE ANTERIOR CHAMBER. SHE STATED THAT DURING THE SURGERY SHE WAS AWAKE AND HEARD THE DR. ASK FOR "A SIZE 4" TO WHICH HE WAS TOLD BY STAFF THAT IT WAS OUT OF STOCK AND ONLY A "SIZE 3" WAS AVAILABLE. SHE WAS UNSURE WHAT THIS REFERRED TO. THE PATIENT HAD A HISTORY OF OCULAR AND RETINAL CONDITIONS UNRELATED TO THE CATARACT SURGERY. POSTOPERATIVELY, SHE REPORTED PERSISTENT SORENESS IN THE EYE, SIGNIFICANT LIGHT REFLECTIONS THAT IMPAIR HER ABILITY TO DRIVE AT NIGHT, AND THE PRESENCE OF NUMEROUS FLOATERS. SHE HAS BEEN USING AN UNSPECIFIED GEL LUBRICANT IN THE AFFECTED EYE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH HER SURGEON. HOWEVER, THE SURGEON WAS UNABLE TO EXPLAIN THE CAUSE OF HER SORE EYE, THE PRESENCE OF NUMEROUS FLOATERS, OR THE EXTENT OF SCATTERED LIGHT IN HER VISION. THE PATIENT CONTINUES TO EXPERIENCE EYE PAIN AND SCATTERED LIGHT I
Patient problems: Eye Pain; Visual Disturbances; Visual Impairment; Vitreous Floaters
MAUDE report 23484599 ↗MalfunctionNov 5, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE SURGEON ATTEMPTED TO LOAD THE IOL INTO THE CARTRIDGE AFTER REMOVING IT FROM THE PACKAGING, THE LENS OPTIC APPEARS TO HAVE SLIGHTLY SCRATCHED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 23476641 ↗MalfunctionOct 27, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKEN WHEN ATTEMPTING TO INSERT IT INTO THE PATIENT EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23391227 ↗MalfunctionOct 24, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN UPON INSERTION. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED, THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379337 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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