MAUDE Adverse Event Report: BAUSCH + LOMB SU MICS NEEDLE 6/B, STRAIGHT, STERILE; UNIT, PHACOFRAGMENTATION

Model Number	BL3318S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable at the time of release.The product has been requested yet not returned.Further investigation pending product return.
Event or Problem Description
A facility in (b)(6) reported that a piece of plastic from the needle wrench was noticed during surgery and was removed from the eye.There was no patient injury.
Additional Manufacturer Narrative
One opened bl3318s pouch from lot w4136 was received.Visual inspection found that the pouch contains the needle wrench/holder only.Microscopic examination found the flats on the needle holder side of the assembly are marred, gouged and bits of material are sticking up on the edges.There are particulates visible around the damaged area.The cause of the damage cannot be determined.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 since there is no non-conformance.Manufacturing and sterilization records were reviewed and found to be acceptable.Review of september 2019 complaint review board trends for stellaris vacuum products showed within control limits for bl3318s.The investigation is complete.

• Brand Name: SU MICS NEEDLE 6/B, STRAIGHT, STERILE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9146876
• Report Number: 0001920664-2019-00198
• Device Sequence Number: 16800238
• Product Code: HQC
• UDI-Device Identifier: 00757770058266
• UDI-Public: (01)00757770058266(17)220308
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019
• Report Date (Section F): 01/01/2005

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?: No
• Operator of Device: No Information
• Device Expiration Date: 03/08/2022
• Device Model Number: BL3318S
• Device Lot Number: W4136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005