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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been requested for evaluation.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
During a cataract procedure the cutter had difficulty cutting.No medical intervention or treatment was required.
Additional Manufacturer Narrative
One opened bl5525w pack from lot v9954 was received.The assembly was clean and dry.The tubing was still coiled and taped together.The cutter had been removed from the tubing and was in the tip protector, positioned incorrectly.The needle was not bent.The port window was in the opened position.There was no evidence of dried solution in the tubing.The ends of the tubing were stretched and have the shape of the barbs on the back of the cutter cap; indicating that the tubing has once been attached to the back cap.The connectors were inspected and no damaged was found.After reassembling the tubing onto the cutter, a functional test was performed using a stellaris pc system.The cutter had good clean cuts and had good aspiration.The cutter performed as intended.

• Brand Name: 25 GAUGE COMBINED PROCEDURE PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7757058
• Report Number: 0001920664-2018-00096
• Device Sequence Number: 11092742
• Product Code: HQC
• UDI-Device Identifier: 20757770058185
• UDI-Public: (01)20757770058185(17)190128
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 07/13/2018

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: 01/28/2019
• Device Model Number: BL5525W
• Device Lot Number: V9954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1