OPTILINK 42.231.295SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982259615), received between Jun 17, 2021 and Jun 17, 2021 — 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 5.0 VAL SCREOPTILINK SLF-TPNG/SD/95-S. THIS REPORT IS 13 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017991 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 5.0 VAL SCREOPTILINK SLF-TPNG/SD/95-S. THIS REPORT IS 8 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017980 ↗