TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 19.5D CYL2.25 · Class 3 · Implant
All models of TECNIS ODYSSEY TORIC II IOL (106)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474811935), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2024Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TORIC WAS DAMAGED IN THE PRELOADED INJECTOR AND IT WAS NOT IMPLANTED. THE SURGERY TECH (VERY EXPERIENCED TECH) TOLD THE SURGEON THAT THE PLUNGER WOULD NOT ADVANCE AND SHE DIDN'T WANT TO PUT ANY MORE FORCE ON IT. THE SURGEON INSPECTED IT UNDER THE SCOPE BUT COULD NOT SEE WHY IT WOULD NOT ADVANCE. AS THE CUSTOMER ONLY ORDER ONE LENS AND NO BACKUP, BEFORE LEAVING THE PATIENT APHAKIC, AND THE SURGEON HOPED THAT HE COULD SALVAGE THE IOL AND LOAD IT MANUALLY. THE SURGEON THEN CUT THROUGH THE INJECTOR PLASTIC BEHIND THE LENS. ONCE THE SURGEON HAD A SMALL WINDOW TO SEE THE LENS, HE COULD SEE THAT ONE OF THE HAPTICS HAD BROKEN OFF, THEREFORE HE KNEW THAT HE COULD NOT SALVAGE THE IOL. REGARDLESS, THE SURGEON LEFT THE PATIENT APHAKIC. IT WAS NOTED THAT THERE WAS NO PATIENT CONTACT WITH THE PRODUCT AND THAT A SECONDARY IOL PLACEMENT WILL OCCUR WHEN IOL ARRIVES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163563 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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