LATITUDE

Description of Event or Problem

INITIAL REPORT: DECEMBER 18, 2023 FDA CONTACTED MANUFACTURER REPORT # MW5147863 RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. COMPANY IS PROCEEDING WITH AN INVESTIGATION RELATED TO THIS EVENT. FOLLOW-UP/CLOSING REPORT; (B)(6) 2024: THE PATIENT WAS SEEN FOR AN ANNUAL VISIT ON (B)(6) 2024. NO TREATMENT WAS PRESCRIBED BY THE DOCTOR IN RELATION TO THE INCIDENT. THE PATIENT DID NOT REPORT ANY INJURIES REGARDING THIS INCIDENT AT THE TIME OF HIS ANNUAL EXAM. THE PATIENT'S EYE CARE PROVIDER ORDERED A NEW PAIR OF CONTACT LENSES, DIFFERENT DESIGN/MATERIAL.

Additional Manufacturer Narrative

INITIAL REPORT: MANUFACTURER COMPANY IS PROCEEDING WITH INVESTIGATION (COMPLAINT # (B)(4)) RELATED TO THIS EVENT (MEDWATCH MW5147863). COMPANY WILL FILE A FOLLOW UP REPORT. "THIS REPORT IS BEING FILED IMMEDIATELY AFTER THE MANUFACTURER WAS GRANTED ACCESS TO WEBTRADER" FOLLOW UP/CLOSING REPORT JANUARY 16, 2024 A THOROUGH INVESTIGATION OF THE COMPANY'S COMPLAINT RECORDS, MATERIAL/MATERIAL LOT NUMBER, AND PRODUCT DESIGN WAS COMPLETED. NO FINDINGS INDICATE THIS INCIDENT WAS DUE TO MATERIAL OR A DESIGN DEFECT (FULL INVESTIGATION REPORT DOCUMENTED IN COMPANY COMPLAINT # (B)(4). COMPANY COMPLETED INVESTIGATION OF THIS EVENT, NO FINDINGS TO REPORT.

Additional Manufacturer Narrative

MANUFACTURER COMPANY IS PROCEEDING WITH INVESTIGATION COMPLAINT # (B)(4) RELATED TO THIS EVENT (MEDWATCH MW5147863). COMPANY WILL FILE A FOLLOW UP REPORT. "THIS REPORT IS BEING FILED IMMEDIATELY AFTER THE MANUFACTURER WAS GRANTED ACCESS TO WEBTRADER"

Description of Event or Problem

DECEMBER 18, 2023 FDA CONTACTED MANUFACTURER REPORT # MW5147863 RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. COMPANY IS PROCEEDING WITH AN INVESTIGATION RELATED TO THIS EVENT.