Aaris Acrylic Intraocular lens(IOL) EC-3 PAL (UDI 00884872025381)Recalls & reported problems
Aaren Scientific Inc. · Class 3 · Implant
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 00884872025381), received between Oct 3, 2017 and Oct 3, 2017 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Eye Injury1
- Patient Problem/Medical Problem1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2017, TWO EC-3 PAL LENSES WERE IMPLANTED INTO THE PATIENT'S EYES. FIFTEEN (15) DAYS POST-OPERATION, THE PATIENT SUFFERED FROM SOME SORT OF FUNGAL GROWTH IN HER LEFT EYE. THE RIGHT EYE HAD NO ISSUES. THE LEFT EYE LENS WAS REMOVED AND FUNGAL GROWTH TREATED WITH ANTIBIOTICS BUT SHOW NO IMPROVEMENT. THE PATIENT'S VISION IS IMPACTED AND REPLACEMENT OF THE LENS SEEMS NOT TO BE AN OPTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Eye Injury; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 6909725 ↗
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- 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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