Multiflex MTA3U0 (REF MTA3U0.190)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380650701268), received between Jul 2, 2022 and Jun 13, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- Adhesion(s)1
- Inflammation1
- Intraocular Pressure Increased1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2024Malposition of Device; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL) WAS CAPTURED BY THE IRIS, MEANING THAT IT WAS POSTERIOR OR BEHIND THE IRIS THAN IN FRONT OF IT. SO, IN THIS CASE THE HAPTIC WAS IN FRONT OF THE IRIS, BUT THE NASAL AND TEMPORAL SIDE OF THE OPTIC WAS BEHIND THE IRIS RATHER THAN IN FRONT, CAUSING IRIS CHAFFING AND PERSISTENT INFLAMMATION. ACIOL WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Adhesion(s); Inflammation
MAUDE report 19528478 ↗InjuryJul 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS NOT STABLE DUE TO HIGH VITREOUS PRESSURE. THE EVENT OCCURRED DURING RIGHT EYE CATARACT SURGERY (WITH IOL IMPLANT). THUS, DR. DECIDED TO EXPLANT THE LENS AND LEFT APHAKIC FOR THIS PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE IS PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Intraocular Pressure Increased
MAUDE report 14897516 ↗
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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