Multiflex MTA3U0 (REF MTA3U0.200)Recalls & reported problems
Alcon Laboratories, Inc. · MULTIFLEX(TM*)III SINGLE-PIECE PMMASTERILE ACL (IOL/AC), 12.5mm LENGTH, 5.5mmCONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF. · Class 3 · Implant
All models of Multiflex (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380650701282), received between Jul 27, 2021 and Nov 5, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Scratched Material1
Patient problems
- Capsular Bag Tear1
- Insufficient Information1
- Vitreous Loss1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION, COMPLICATION HAPPENED, POSTERIOR CAPSULE RENT DUE TO SURGICAL FACTOR. DOCTOR DECIDED TO IMPLANT LENS IN ANTERIOR CHAMBER, HOWEVER, AFTER IMPLANTATION, VITREOUS LOSS, SUSPECT CAUSED BY INITIAL POSTERIOR CAPSULE RENT, HENCE, DOCTOR DECIDED TO EXPLANT THE IMPLANTED LENS AND LEAVE THE PATIENT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear; Vitreous Loss
MAUDE report 12228082 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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