TECNIS CL IOL Z9002 (REF Z900200060)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 6.0 · Class 3 · Implant
All models of TECNIS CL IOL (42)
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 05050474530416), received between Dec 21, 2017 and Oct 27, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available1
- Retinal Detachment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO SILICONE OIL. ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER SURGICAL INTERVENTIONS WERE REQUIRED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THERE WAS RETINAL DETACHMENT AND THE LENS WAS EXPLANTED ALONG WITH RESIDUAL SILICONE OIL. POST-EXPLANT, THE PATIENT WAS HEALING WELL WITH ELEVATED INTRAOCULAR PRESSURE OBSERVED ON DAY 1 POST-OPERATION THAT IMPROVED WITH DECOMPRESSION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Retinal Detachment
MAUDE report 15687001 ↗InjuryDec 21, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A Z9002 6.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017. REPORTEDLY, THE A-SCAN MEASUREMENTS WERE IN ERROR. LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATION; THERE WAS NO PRODUCT QUALITY ISSUE WITH LENS, NO PATIENT INJURY, NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL, A 23.0, LARGER, DIOPTER LENS. PATIENT OUTCOME WAS REPORTED AS GOOD, NO PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7140691 ↗
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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