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LENS 72204725SRecalls & reported problems

Smith & Nephew, Inc. · SERVICE REPLACEMENT COUPLER HD 17.2MM AUTOCLAVABLE · Class 2

All models of LENS (8)

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 00885556632048), received between May 31, 2021 and May 31, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

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.

  • MalfunctionMay 31, 2021Crack; Crack

    IT WAS REPORTED THAT, DURING SET UP, THE "HD COUPLER 17.2MM" WAS NOTICED TO BE BLURRY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACKED DISTAL WINDOW WHICH MAKES IT A REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11907499 ↗

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Sources and updates

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