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	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.The product was not available for return; therefore, and evaluation cannot be performed.It is unknown if this product was used with a valved cannula.If so, directions warn, only retractable ddms products are compatible with valved cannula systems.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.
Event or Problem Description
The user facility reported there was some dust in the eye of the retina peel cases.The surgical team was not sure if it could have come from the instrument.The surgeon was able to aspirate the dust out and follow up showed no issues.

• 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: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 21208083
• Report Number: 0001932402-2025-00001
• Device Sequence Number: 3943128
• Product Code: GZX
• UDI-Device Identifier: 20841305108848
• UDI-Public: (01)20841305108848(17)270221(10)M0052987
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 01/02/2025

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 Model Number: 20.04.25S
• Device Lot Number: M0052987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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