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	Retinal Detachment (2047)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported via clinical study that during a vitrectomy surgery while using an ophthalmic disposable product the patient experienced retinal detachment.No further information expected as the details were received from a clinical study.
Additional Manufacturer Narrative
Corrected information is provided in sections b.2 and h.10.Based on the information received following submission of the initial report, it was clarified that the adverse event experienced by the patient is unrelated to the ophthalmic disposable product reported in the file.No further reports will be scheduled under mfg report num.3003398873-2023-00066.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: 17117286
• Report Number: 3003398873-2023-00066
• Device Sequence Number: 15115661
• Product Code: HJI
• UDI-Device Identifier: 07612717071285
• UDI-Public: 07612717071285
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 06/20/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female