LATERA LATSYS24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00857037006075), received between Mar 14, 2023 and Jul 22, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Migration

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25907615 ↗
• MalfunctionJun 18, 2026Migration

  IT WAS REPORTED THAT THE PATIENT'S IMPLANT MIGRATED AND ADDITIONALLY HAD A RETINAL DETACHMENT ON THE SAME SIDE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. THERE IS NO INDICATION THAT THE RETINAL DETACHMENT WAS CAUSED OR CONTRIBUTED BY THE DEVICE. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THE LATERA MIGRATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25551946 ↗
• MalfunctionNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT HAS NASAL IMPLANT THAT HAS NOT RESORBED AFTER 2 YEARS WHICH IS CAUSING BULGE ON THE NOSE. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS.

  Patient problems: Implant Pain; Subcutaneous Nodule

  MAUDE report 23586677 ↗
• MalfunctionAug 5, 2025Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  IT WAS REPORTED THAT A PATIENT'S NASAL IMPLANT HAS NOT ABSORBED AND IS NOTICEABLE ON THE SIDE OF THEIR NOSE. IT WAS ALSO REPORTED THAT IT IS PAINFUL TO WEAR GLASSES FOR LONG PERIODS OF TIME. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS.

  Patient problems: Implant Pain

  MAUDE report 22719502 ↗
• MalfunctionJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT'S NASAL IMPLANT HAS NOT DISSOLVED AFTER BILATERAL IMPLANTATION IN 2022. THE SURGEON NOTED THE IMPLANT FORKS ARE VISIBLE, PALPABLE AND PAINFUL IN THE PATIENT. THE SURGEON WAS ADVISED TO EXPLANT THE DEVICE FROM THE PATIENT BY STRYKER CONSULTANT. THE PATIENT WAS ADMINISTERED WITH KENALOG INJECTION, HOWEVER THE IMPLANT WAS UNABLE TO BE EXPLANTED. NO FOLLOW-UP APPOINTMENTS HAVE BEEN SCHEDULED TO SEE THE PATIENT AT THIS TIME.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 22522929 ↗
• MalfunctionMay 29, 2025Migration; Migration

  IT WAS REPORTED THAT THE LATERA IMPLANT WAS PLACED BILATERALLY IN (B)(6) 2024 AND THE RIGHT LATERA IMPLANT MIGRATED UPWARDS APPROXIMATELY 1 MM AWAY FROM THE TEAR DUCT AND OCCURRED SEVERAL HOURS AFTER THEY WERE IMPLANTED. THE PATIENT HAS REPORTED DIFFICULTY IN BREATHING THROUGH THE RIGHT NOSTRIL. THERE HAS BEEN NO REPORTED MEDICAL INTERVENTION. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED.

  Patient problems: Obstruction/Occlusion; Tissue Breakdown; Unspecified Respiratory Problem

  MAUDE report 22109028 ↗
• InjuryMar 30, 2023Expulsion; Expulsion

  IT WAS REPORTED THAT A YEAR AFTER THE PATIENT HAD LATERA IMPLANTS PLACED THE PATIENT WAS EXPERIENCING DISCOMFORT WHEN WEARING GLASSES AND STATED THE DEVICE DID NOT WORK AS INTENDED. THE PATIENT HAD AN ADDITIONAL PROCEDURE TO REMOVE THE IMPLANTS, ALTHOUGH THEY HAD DISSOLVED AND WERE NOT ABLE TO BE REMOVED. NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648804 ↗
• InjuryMar 14, 2023Expulsion; Patient Device Interaction Problem; Expulsion; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LATERA IMPLANT PROCEDURE ON (B)(6) 2020. THE PATIENT REPORTED THAT NEARLY 2 YEARS LATER THE IMPLANT DID NOT DISSOLVE AND COULD STILL FEEL THE IMPLANT THROUGH HER SKIN. AN ADDITIONAL PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538036 ↗