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

Model Number BL5110

Device Problem Difficult to Insert (1316)

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

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

The sterilization and lot history records were reviewed and found to be acceptable.

Event 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.

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.

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
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 636226-322
• MDR Report Key: 6552689
• MDR Text Key: 74701200
• Report Number: 0001920664-2017-00172
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010(17)180325
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1