MAUDE Adverse Event Report: BAUSCH + LOMB 25GA HIGH-FLOW I.I.C.; ENDOILLUMINATOR

Model Number 56.34.25P

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported the user facility had a microscopic glass part fall onto the posterior segment on the retina.The surgeon removed the lens with a 25g vitrector.

Manufacturer Narrative

Product is not able to be returned as it was discarded.The investigation is ongoing.

Manufacturer Narrative

Additional information, d4.

Manufacturer Narrative

A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.

• Brand Name: 25GA HIGH-FLOW I.I.C.
• Type of Device: ENDOILLUMINATOR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; st. louis MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 636226-318
• MDR Report Key: 16009326
• MDR Text Key: 308276295
• Report Number: 0001932402-2022-00006
• Device Sequence Number: 1
• Product Code: MPA
• UDI-Device Identifier: 20841305107438
• UDI-Public: (01)20841305107438(17)250812
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K952586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 56.34.25P
• Device Catalogue Number: 56.34.25P
• Device Lot Number: M0044445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1