Aaris Acrylic Intraocular lens(IOL) EC-3 PAL (UDI 00884872025350)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 00884872025350), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Optical Decentration” (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 18, 2026.
Most reported problems
Device problems
- Optical Decentration1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2016Optical Decentration; Optical Decentration
IT WAS REPORTED THAT ON (B)(6) 2016 A 20.5 DIOPTER EC_3 LENS WAS IMPLANTED. AFTER IMPLANTATION, IT WAS NOTED THAT, THE LENS WANT TO TILT BUT EVEN THEN, THE LENS WAS LEFT IN THE PATIENT. THE FOLLOWING DAY, IT WAS NOTED THAT THE HAPTIC HAD COMPLETELY DISLODGED FROM THE OPTIC AND THE HAPTIC REMAINED ATTACHED TO THE TUNNEL. ON (B)(6) 2016, THE LENS WAS EXPLANTED AND ANOTHER LENS IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED OF ANY CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. USER FACILITY MEDWATCH STATED: RIGHT EYE APHAKIA AND PATIENT NO LONGER ABLE TO PLACE CONTACT LENS AND WAS ADMITTED FOR SECONDARY IOL INSERTION WITH PLANNED (SCLERAL FIXATED/GLUED IOL AND ANTERIOR VITRECTOMY TO RIGHT EYE) PROCEDURE WENT WELL WITH NO COMPLICATIONS. ON FOLLOW-UP VISIT EXAM WITH HAPTICS VISIBLE AND IN GOOD POSITON; HOWEVER, NASAL HAPTIC DISLOCATED FROM OPTIC ANS WILL NEED TO BE REPLACED. THE PATIENT UNDERWENT REMOVAL OF FAILED LENS AND REPLACED WITH ANOTHER EC_3 PAL LENS. POST-OP THE PATIENT IS DOING WELL WITH SMALL HOME SECONDARY TOD BLOOD THINNERS, EXPECT VISUAL ACUITY TO IMPROVE AS HEME RESOLVES.
Patient problems: Visual Disturbances
MAUDE report 6176096 ↗
Other Intraocular Lens devices
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- 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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