MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSPONGE; OPHTHALMIC SPONGE

Catalog Number	8065100003
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2023
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 customer reported microsponge disintegrates and leaves fibers in the interface of the lasik and on the conjunctiva.The debris was often not visible until the next day and cannot be removed without a new procedure in the operating room.Re-intervention to remove debris was performed.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSPONGE
• Common Device Name: OPHTHALMIC SPONGE
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16460493
• Report Number: 2523835-2023-00093
• Device Sequence Number: 6572676
• Product Code: HOZ
• UDI-Device Identifier: 00380651000032
• UDI-Public: 00380651000032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K896004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065100003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/02/2023
• 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: Required Intervention
• Patient Sex: Unknown