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

Model Number BL5110

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation.Manufacturing and sterilization records were reviewed and found to be acceptable.

Event 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
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 7538628
• MDR Text Key: 109094512
• Report Number: 0001920664-2018-00059
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010(17)190608
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2019
• Device Model Number: BL5110
• Device Lot Number: W0891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1