MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMB PK W V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5523WV
Medical Device Problem Codes	Failure to Cut (2587); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device used during the reported event was discarded by the hospital according to safety policy.
Event or Problem Description
A report from a user facility in (b)(6) stated that according to the surgeon the cutter was making a sound that was different from normal and also appeared not to be working correctly.A new cutter from a different pack was used instead to complete the procedure.There was no report of injury or consequences to the patient.
Additional Manufacturer Narrative
We have received additional information from the reporting facility indicating that the original description of the event was not accurate.The cutter was indeed cutting but was not adequately aspirating despite attempted aspiration external to the patient's eye.As a result of this additional information, it has been determined that the issue documented in this report does not meet the criteria of a reportable malfunction and the complaint record will be revised accordingly.

• Brand Name: 23GA COMB PK W V&AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6789391
• Report Number: 0001920664-2017-00264
• Device Sequence Number: 121688
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)180728
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: BL5523WV
• Device Catalogue Number: BL5523WV
• Device Lot Number: V8790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1