inforMED
InjuryHQD

SYNERGEYES K LENS

Received Jul 8, 2024 · Event occurred Apr 26, 2024

Report 3005087645-2024-00002 · MDR key 19695538

Device

Generic name

Daily Wear Hybrid Contact Lens

Manufacturer

Synergeyes

Model number

KS6782-0800

Catalog number

KS

Lot number

117216

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Corneal Ulcer
  • Corneal Ulcer

Narrative

Description of Event or Problem

06/10/2024: POTENTIAL INJURY WAS RECEIVED AT RETURNS DEPT. 06/27/2024: POTENTIAL INJURY (COMPLAINT) WAS PROCESSED AND RECEIVED BY QA AND CONSULTATION DEPARTMENT. CONSULTATION DEPT. REACHED OUT TO EYE CARE PROFESSIONAL TO GET ALL DETAILS REGARDING REPORTED ISSUE. QA INSPECTED LENS AND THERE WERE NO MANUFACTURING DEFECTS FOUND WITH THE CONTACT LENS. 06/27/2024: CONSULTATION DEPT. SPOKE WITH ECP TECHNICIAN WHO RELAYED INFORMATION FROM DR. (B)(4) - PATIENT PHONED/ CAME IN WITH PAIN AND PHOTOPHOBIA OS. UPON SLIT LAMP EVALUATION OS CORNEAL ULCER WAS DIAGNOSED. IT WAS MINOR AND ONLY INVOLVED THE EPITHELIAL LAYER OF THE CORNEA. PT WAS GIVEN TOBRAMYACIN AND OFLOXACIN DROPS OS FOR 7 DAYS, 2 DROPS FOUR TIMES A DAY. ONCE DROP REGIMEN WAS COMPLETED, PT WAS EVALUATED AGAIN. VA RESUMED WITHIN NORMAL LIMITS. CORNEA WAS WITHIN NORMAL LIMITS, NO RESIDUAL SCAR. CORNEA WAS CLEAR OS.

Remedial action

  • Other