TECNIS IOL ZCU150 (REF ZCU150U095)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 09.5D CYL1.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474657588), received between Jun 27, 2024 and Jun 27, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A DOCTOR REPORTED OF A PLANNED EXPLANT OF A RECENT PATIENT WHO WAS UNHAPPY WITH A TORIC INTRAOCULAR LENS (IOL) IMPLANTED IN HIS RIGHT EYE. IT WAS INDICATED THAT THE LENS WAS SET TO A MILD MYOPIC AIM. THE PATIENT ENDED UP MORE MYOPIC THAN ANTICIPATED DUE TO UNCONTROLLABLE FACTORS. THE PATIENT IS NOW UNHAPPY SINCE HE WOULD LIKE TO SEE DISTANCE MORE CLEARLY. THROUGH A FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL, BUT LOWER DIOPTER (8.0D) WAS USED A REPLACEMENT. THERE WAS NO VITRECTOMY PERFORMED, NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 19630524 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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