MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA COMBINED PROCEDURAL PACK WITH WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5523W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Further investigation underway.
Event or Problem Description
The user facility in mauritius reported one of the trocar broke in the patient's eye at the end of the vitrectomy procedure.The incision was enlarged to remove the cannula.There was no impact or injury to the patient.The patient is stable.
Additional Manufacturer Narrative
Although the product was not returned for evaluation, photos were supplied by the customer.It appears the polyamide sleeve has separated from the trocar.However, the product was not returned for evaluation.The cause is unknown.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Investigation complete.

• Brand Name: 23 GA COMBINED PROCEDURAL PACK WITH WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8518899
• Report Number: 0001920664-2019-00071
• Device Sequence Number: 1839447
• Product Code: HQC
• UDI-Device Identifier: 20757770058178
• UDI-Public: (01)20757770058178(17)190708
• Combination Product (Y/N): Y
• Initial Reporter Country: MP
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/08/2019
• Device Model Number: BL5523W
• Device Lot Number: W1141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention