MAUDE Adverse Event Report: ALCON GRIESHABER AG CURVED MEMBRANE SCRAPER; SPATULA, OPHTHALMIC

Catalog Number	338.27
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during a combination of cataract and vitrectomy surgery an ophthalmic scraper tip loop did not come out.Procedure was completed using another product.There was no patient harm.
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
Additional information was provided in sections d.9, h.3, h.6 and h.10.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample is received with inner blister and without outer blister or cover foil.The sample shows no macroscopic signs of damage.The sample shows signs of surgery residues and is returned in a opened status.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was visually tested and functionally tested.It was noticed that the loop does not extend far enough.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.The customer¿s complaint is confirmed.It cannot be determined how or where the damage to the sample occurred; therefore, a root cause for the customers reported event could not be determined.However, the damage was consistent with damage that can occur due to improper handling.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: CURVED MEMBRANE SCRAPER
• Common Device Name: SPATULA, OPHTHALMIC
• 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: 16451844
• Report Number: 3003398873-2023-00030
• Device Sequence Number: 20292357
• Product Code: HND
• UDI-Device Identifier: 07612717071452
• UDI-Public: 07612717071452
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 04/20/2023

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 Catalogue Number: 338.27
• Device Lot Number: ASKU
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown