MAUDE Adverse Event Report: BAUSCH + LOMB STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER (DDMS¿); INSTRUMENT, MICROSURGICAL

Model Number	20.04.25S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported during a retina case the product was leaving diamond dust behind.They discontinued using the membrane scrapper.Another membrane scrapper was opened on the field and used without any issues.The doctor later reported the diamond dust was removed with vitrector and soft tip extrusion cannula.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
The complaint condition could not be replicated as the silicone tip to which the diamond dust is bonded was not present on the returned product or in the packaging.The portion of silicone bead still present and visible inside the shaft has a rough irregular surface consistent with having been torn.Instructions for use state: only retractable ddms products (20.16, 20.16.23, 20.16.25) are compatible with valved cannula systems.Use of other ddms products (20.04, 20.04.23, 20.04.25s, 20.04.27, 20.07, 20.18) with valved cannula systems may damage flexible tip.The hospital confirmed that this device was being used with an valved cannula.This is a contraindicated action.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER (DDMS¿)
• Common Device Name: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22034235
• Report Number: 0001932402-2025-00004
• Device Sequence Number: 18339980
• Product Code: GZX
• UDI-Device Identifier: 20841305108848
• UDI-Public: (01)20841305108848(17)260321(10M0047626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: A800891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 03/21/2026
• Device Model Number: 20.04.25S
• Device Lot Number: M0047626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (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