Multiflex MTA4U0 (REF MTA4U0.050)Recalls & reported problems
Alcon Laboratories, Inc. · MULTIFLEX™*III SINGLE-PIECE PMMA STERILE ACL (IOL/AC), 13.0mm LENGTH, 5.5mm CONVEXOPLANO 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652535595), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 injury.
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
Patient problems
- Eye Pain1
- Visual Disturbances1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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