MAUDE Adverse Event Report: BAUSCH + LOMB BASIC VACUUM PHACO 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	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The surgeon reported the sleeve did not enter the incision smoothly and was difficult to insert.There was no reported impact to the patient.
Additional Manufacturer Narrative
Evaluation completed.One blue irrigation sleeve was returned in a test chamber.The original packaging was not returned."bl5110 v8157" was hand written on the mailing envelope.Visual inspection found the assembly dirty with particulates and dried solutions all over it.No defects were found.Dimensional measurements of the wall thickness was not performed at this facility due to the destructive nature of the test.However, this sample will be sent to the vendor for full test and dimensional measuring.
Additional Manufacturer Narrative
Vendor evaluation completed: the suspect soft sleeve was too thin dimensionally for an accurate durometer reading the vendor has on site.It was placed on a pin gauge and estimated durometer readings were similar to a sleeve to have known acceptable durometer.The device history was reviewed and found to meet manufacturing specification.

• Brand Name: BASIC VACUUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6552689
• Report Number: 0001920664-2017-00172
• Device Sequence Number: 19119906
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010(17)180325
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2017

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: Physician
• Device Expiration Date: 03/25/2018
• Device Model Number: BL5110
• Device Lot Number: V8157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided; 06/15/2017
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 06/13/2017; 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1