TECNIS IOL DXR00V (REF DXR00VU125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLCTY TECNIS SYMF ERV OB 12.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474761643), received between Aug 25, 2023 and Jan 2, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Halo2
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT DID NOT ADAPT WELL TO THE HALOS AND GLARES. THE IOL WAS REPLACED WITH A DIFFERENT JOHNSON AND JOHNSON LENS MODEL ZCB00, 13.0 DIOPTER. THE CUSTOMER WAS ASKED IF THERE WERE COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR MEDICATION TO PREVENT PERMANENT IMPAIRMENT. THE CUSTOMER RESPONDED AS N/A, NOT APPLICABLE. THE PATIENT OUTCOME WAS ALSO SUPPLIED AS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 21062893 ↗InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT RIGHT EYE. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF NEGATIVE DYSPHOTOPSIA. REPLACED THE LENS OF THE RIGHT EYE WITH A NON-J&J MONOFOCAL IOL. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT NOW HAVE FEWER HALOS AND STILL HAVE INFERIOR QUADRANT VISION LOSS (OD> OS) AND DOING BETTER. THERE WAS INCISION ENLARGEMENT. NO OTHER PATIENT INJURY AND SUTURE/VITRECTOMY WERE NOT REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances; Visual Impairment
MAUDE report 17628618 ↗
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- 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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