MAUDE Adverse Event Report: ALCON GRIESHABER AG LAUREATE ANTERIOR VITRECTOMY TIP; UNIT, PHACOFRAGMENTATION

Catalog Number	180.01
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
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 that ophthalmic cutter on the operating console was not working during the surgery.The surgery was completed after replacing the product with another one.No patient impact was reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6., and h.11.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any relevant deviation and that there are no complaints associated with it other than this report.The investigation is concluded based on the sample evaluation outlined below.The returned instrument was delivered in its inner and outer blister covered with the tyvek foil showing the lot information.The instrument shows no macroscopic signs of damage and no obvious surgical residue.The product was visually inspected using a photomicroscope at various magnifications.The visual inspection showed no abnormalities.The instrument was then tested, and it was noted that opening and closing worked, but that there was some scratching.The customer's complaint is therefore confirmed.It cannot be determined how or where the damage to the sample occurred.Therefore, a root cause for the customer's reported event could not be determined conclusively the exact root cause for the customer's reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: LAUREATE ANTERIOR VITRECTOMY TIP
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 20013313
• Report Number: 3003398873-2024-00090
• Device Sequence Number: 4375997
• Product Code: HQC
• UDI-Device Identifier: 07612717064621
• UDI-Public: (01)07612717064621(17)250331(11)220406(10)14H1XK
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K911808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 180.01
• Device Lot Number: 14H1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown