MAUDE Adverse Event Report: BAUSCH + LOMB PREMIUM PHACO VACUUM PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5110
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for evaluation.Manufacturing and sterilization records were reviewed and found to be acceptable.
Event or Problem Description
The customer reported that a blue particle was observed in the eye.The particle was removed from the eye.

• Brand Name: PREMIUM PHACO VACUUM PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7538628
• Report Number: 0001920664-2018-00059
• Device Sequence Number: 2482560
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010(17)190608
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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: 06/08/2019
• Device Model Number: BL5110
• Device Lot Number: W0891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1