GRIESHABER DSP SURGICAL CONTACT LENS

Description of Event or Problem

A CUSTOMER REPORTED VIA A CLINICAL STUDY THAT AFTER A VITRECTOMY SURGERY WITH THE USE OF AN OPHTHALMIC DISPOSABLE PRODUCT A PATIENT EXPERIENCED IRRITATION AND RETINAL INFLAMMATION. THE PATIENT REQUIRED INTERVENTION (UNKNOWN IF SURGICAL OR MEDICAL) AND THE EVENT IS RESOLVED. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

THE REPORTED EVENT WAS REPORTED IN ERROR. FOR THIS EVENT; THIS REPORT OF ¿IRRITATION¿ DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿ THE REPORTED DEVICE USED DURING THE PROCEDURE IS USED ON THE ANTERIOR SURFACE OF THE EYE TO VISUALIZE FUNDUS AND RETINAL STRUCTURES DURING VITREORETINAL SURGERIES AND IS NOT USED IN THE INTERIOR OF THE EYE TO EXECUTE AND OR PERFORM A SURGICAL ACTION. THERE IS NO INDICATION THAT THE DEVICE CONTRIBUTED TO THE EVENT OR ANY ALLEGATION THAT OF A DEVICE MALFUNCTION OR DETERIORATION THE CHARACTERISTICS OR PERFORMANCE IN RELATION TO THE EVENT. THERE IS NO INDICATION OF DEVICE FAILURE AS THE DEVICE WAS USED AND PERFORMED AS INTENDED. NO FURTHER REPORTS WILL BE REPORTED UNDER MFG REPORT NUM. 3003398873-2023-00150. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

THE INITIAL REPORT WAS REPORTED IN ERROR. AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT WHILE USING A SURGICAL MACULAR LENS A PATIENT EXPERIENCED ¿IRRITATION¿ DURING A VITREORETINAL SURGERY. THE SYMPTOMS WERE RESOLVED. FOR THIS EVENT; THIS REPORT OF ¿IRRITATION¿ DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿