MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT PHACOEMULSIFICATION

Model Number	BL5113
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in italy reported some glittering material was noticed in the front chamber of the eye at the end of the phaco phase.The material was removed with irrigation/aspiration.After the surgery, the surgeon analyzed the tip under a microscope and noticed it was missing pieces of paint.There was no impact or injury to the patient.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
Device evaluation: one purple needle tip and the needle wrench were returned with a bl5113 pack label from lot x3258.Visual inspection found the needle was heavily damaged on the tip with gouges, marring, scratches, dings, and material missing around the tip and on the flats of the hub.There were what looked like tracks or trails which was similar to damage seen when the needle tip comes in contact with another instrument.There was one area on the shaft of the needle that has faded color.It should be noted that the anodize color is an oxidation layer, it is not a coating.Various factors can influence color fade on the needles after shipment from bausch & lomb, and after multiple uses in the field.This may include handling, re-cleaning, installation activities, abrading or scuffing the needle during any field activities that may be unknown to bausch & lomb.However, it should be noted that the number of uses, the number of cleaning cycles, the cleaning methods used, and the storage and handling conditions for this phaco needle tip are unknown.The exact cause of the heavily damaged tip cannot be determined.It is not possible to determine the root cause of damage on the part returned due to the many unknown factors to which the part was exposed during use.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: STELLARIS MICRO INCISION VACUUM PACK
• Common Device Name: UNIT PHACOEMULSIFICATION
• 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 ; 6362263220
• MDR Report Key: 16520598
• Report Number: 0001920664-2023-00018
• Device Sequence Number: 6561033
• Product Code: HQC
• UDI-Device Identifier: 00757770057238
• UDI-Public: (01)00757770057238(17)251204(10)X3258
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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 Expiration Date: 12/04/2025
• Device Model Number: BL5113
• Device Catalogue Number: BL5113
• Device Lot Number: X3258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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
• Patient Sex: Unknown