MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER DSP SURGICAL CONTACT LENS; LENS, FUNDUS, HRUBY, DIAGNOSTIC

Catalog Number	618.60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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).

• Brand Name: GRIESHABER DSP SURGICAL CONTACT LENS
• Common Device Name: LENS, FUNDUS, HRUBY, DIAGNOSTIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17198722
• Report Number: 3003398873-2023-00127
• Device Sequence Number: 6798977
• Product Code: HJI
• UDI-Device Identifier: 07612717071285
• UDI-Public: 07612717071285
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 618.60
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VOLK SINGLE USE LENSES
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male