MalfunctionHJZ
PTOSE UP
Received Feb 23, 2023 · Event occurred Dec 16, 2022
Report MW5115155 · MDR key 16437241
Device
Generic name
Crutch, Ptosis
Manufacturer
Fci Ophthalmics / Fci SasCatalog number
SC 3021
Lot number
2201084
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Eye Infections
- Eye Infections
Narrative
Description of Event or Problem
SURGERY #2 WAS PERFORMED ON (B)(6) 2022 AND THE IMPLANT WAS REMOVED ON (B)(6) 2022 SECONDARY TO AN INFECTED FRONTALIS SLING OF THE LEFT EYE (MAY BE THE RT EYE AS THE TWO OPERATIVE REPORTS LIST RT EYE ON THE ORIGINAL SURGERY AND LT ON THE IMPLANT REMOVAL). PURULENT DRAINAGE WAS ALSO NOTED. THE CULTURE GREW 1+ STAPHYLOCOCCUS AUREUS WITHIN 24 HOURS OF THE SPECIMEN BEING SENT TO THE LAB.