MAUDE Adverse Event Report: BAUSCH + LOMB TSV POSTERIOR VITRECTOMY PACK WITH AFI; UNIT. PHACOFRAGMENTATION

Model Number	BL5425WV
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	Retinal Injury (2048)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
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
The user facility reported the vitrectomy cutter was not aspirating during surgery.The surgeon moved the cutter causing traction on the retina resulting in a retinal detachment.

• Brand Name: TSV POSTERIOR VITRECTOMY PACK WITH AFI
• Common Device Name: UNIT. PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6642904
• Report Number: 0001920664-2017-00233
• Device Sequence Number: 11001312
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)180806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2018
• Device Model Number: BL5425WV
• Device Lot Number: V8844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1