MAUDE Adverse Event Report: BAUSCH + LOMB 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE; OPHTHALMIC LASER SYSTEM BEAM GUIDE

Model Number	55.70.25P
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales rep on site for surgery reported the laser probe pulled the trocar out of the patients eye.The surgery was delayed maybe 10 minutes and a suture was required to close the wound.No additional anesthesia required.They were able to complete the surgery with no additional products.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
The needle quality is 100% checked on site before shipping.Also, the 55.70.25p does not come with a cannula or trocar.The trocar id might have contributed to this failure.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: 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE
• Common Device Name: OPHTHALMIC LASER SYSTEM BEAM GUIDE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3845 corporate centre dr.; o''fallon, MO 63368 ; 6362263220
• MDR Report Key: 14699533
• Report Number: 0001932402-2022-00003
• Device Sequence Number: 6608915
• Product Code: HQB
• UDI-Device Identifier: 20841305107094
• UDI-Public: (01)20841305107094(17)241110(10)M0039729
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K954306
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2024
• Device Model Number: 55.70.25P
• Device Catalogue Number: 55.70.25P
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 06/27/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/21/2022; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND DISPOSABLE PACK.
• Patient Sex: Unknown