TECNIS SIMPLICITY DIB00 (REF DIB00U0320)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLICITY TECNIS EYHANCE U 32.0D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
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 05050474732001), received between Apr 14, 2023 and Apr 14, 2023 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DIB00 INTRAOCULAR LENS WAS IMPLANTED. THE PATIENT IS ESSENTIALLY PLANO AND 20/20 IN EACH EYE AND HAPPY THAT HE DID SURGERY BUT PERSISTENTLY BOTHERED A 360 DEGREE MID PERIPHERAL HALO/DISTORTION EFFECT IN EACH EYE. IT GOES AWAY WITH SUNGLASSES. THE PATIENT WAS ALSO BOTHERED BY ARTIFICIAL LIGHTING IN ANY SCENARIO, NATURAL LIGHT SEEMS TO BE OK. ADDITIONAL INFORMATION STATED THAT PATIENT HAD MIDPERIPHERAL 360 DEGREE DISTORTION, BLURRINESS AROUND THE EDGES OF THINGS, LIGHT SENSITIVITY WITH ARTIFICIAL AND INDOOR LIGHTING AND DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. PATIENTS PRE OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 OU, POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY, POST OP VASC WAS 20/25 AND 20/20, BCVA WAS 20/20 OU. UPON FURTHER FOLLOW UP, IT WAS INFORMED THAT PATIENT HAD REPEATED SHORT TREATMENT WITH PREDNISOLONE PHOSPHATE/BROMFENAX COMBINATION DROP TID X 1 WEEK, THEN TWICE A DAY FOR A 1 WEEK (NO APPARENT EFFECT). PATIENT HAS PERSISTENT SYMPTOMS, RECOMMENDED TRIAL OF VUITY BUT NOT CLEAR IF PATIENT HAS PICKED UP, DUE BACK IN CLINIC AT THE TIME OF THIS REPORT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 16747974 ↗
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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