MAUDE Adverse Event Report: BAUSCH + LOMB, INC. SIMCOE DBL BARRELED IA UNT 23G; CANNULA, OPHTHALMIC

Model Number	E4971
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned.The evaluation has yet to begin.The investigation is underway.
Event or Problem Description
The product turned a dark brass color at the head end after one sterilization.During the operation, "metal debris" was observed peeling off onto the patient's cornea.It did not affect the patient's vision and the patient did not feel uncomfortable.No further action was taken.The "metal" debris is still on the cornea.
Additional Manufacturer Narrative
The product evaluation confirmed that the discoloration was due to reaction of the silver solder to sterilization and can be minimized with proper cleaning.Metal debris was not returned for evaluation.Unable to determine root cause(s).Based on all complaint information and investigation activities completed, no corrective action is required.The investigation is complete.

• Brand Name: SIMCOE DBL BARRELED IA UNT 23G
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 20509614
• Report Number: 0001920664-2024-00133
• Device Sequence Number: 7969731
• Product Code: HMX
• UDI-Device Identifier: 00757770434374
• UDI-Public: (01)00757770434374
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K951463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: E4971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male