MAUDE Adverse Event Report: BAUSCH + LOMB 25 GAUGE COMBINED PROCEDURE PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5525W
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product is not available for evaluation.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
During a cataract surgery the vitrectomy cutter stopped cutting yet continued aspirating.There was no patient impact.
Additional Manufacturer Narrative
This report was sent in error.It is a duplicate of 0001920664-2018-00058.Please void this medwatch report.

• Brand Name: 25 GAUGE COMBINED PROCEDURE PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7739425
• Report Number: 0001920664-2018-00092
• Device Sequence Number: 1050061
• Product Code: HQC
• UDI-Device Identifier: 20757770058185
• UDI-Public: (01)20757770058185(17)190324
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K101325
• 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): 07/09/2018

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: 03/24/2019
• Device Model Number: BL5525W
• Device Lot Number: W0399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1