GRIESHABER DSP SURGICAL CONTACT LENS
Received Jun 26, 2023 · Event occurred May 1, 2023
Report 3003398873-2023-00127 · MDR key 17198722
Device
Generic name
Lens, Fundus, Hruby, Diagnostic
Manufacturer
Alcon Grieshaber AgModel number
NACatalog number
618.60
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
A CLINICAL STUDY REVEALED THAT DURING THE MEMBRANE PEELING SURGERY WHILE USING DISPOSABLE LENS A MALE PATIENT EXPERIENCED OCULAR TOXICITY (MACULAR) RESPONSE. PATIENT SYMPTOM'S WAS RESOLVED.
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
NO LOT NUMBER WAS IDENTIFIED AND THEREFORE WITHIN THIS COMPLAINT, THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE IDENTIFIED. THE EXACT ROOT CAUSE FOR THE CUSTOMER¿S REPORTED EVENT IS UNKNOWN. THEREFORE, NO SPECIFIC ACTION CAN BE TAKEN. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Remedial action
- Other