MAUDE Adverse Event Report: BAUSCH + LOMB AVS PHACO PACK W 2/2 SLEEVE; UNIT, PHACOFRAGMENTATION

Model Number	BLV3220000
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
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 user facility reported as the doctor was performing phacoemulsification when a back particle fell into the patients eye.The surgeon was able to remove the particle, and complete the surgery with no impact to the patient.
Additional Manufacturer Narrative
Evaluation completed.One small plastic specimen cup was returned.The pack and the components were not returned.Microscopic examination found a dark round particle stuck to the inside wall of the cup.The particle has the appearance of a bead.It is approximately 100 microns in size.This sample was sent to the lab.Further investigation underway.Manufacturing and sterilization records were reviewed and found to be acceptable.Review of the complaint database revealed no other complaints have been submitted against lot #w1448.Further investigation of the particulate is underway.
Additional Manufacturer Narrative
The lab analysis indicated the bead-like particle consisted primarily of sulfur, sodium and calcium.The shape and elemental concentrations of the sample suggest that it may be an ion exchange resin bead.Similar beads may be found in the filters of water purification systems used by the hospital or manufacturer.Although we are unable to determine the exact origin of the particle, it is possible the bead may have originated from the b+l water purification system therefore additional analysis will be performed to determine if further action is required.A review of the complaint database revealed no other similar complaints have been reported.The manufacturing and sterilization records were reviewed and found to be acceptable with the device meeting all specifications at the time of release.

• Brand Name: AVS PHACO PACK W 2/2 SLEEVE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7635467
• Report Number: 0001920664-2018-00066
• Device Sequence Number: 2281574
• Product Code: HQC
• UDI-Device Identifier: 10757770058409
• UDI-Public: (01)10757770058409(17)190819
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2018

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: Physician
• Device Expiration Date: 08/19/2019
• Device Model Number: BLV3220000
• Device Lot Number: W1448
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 08/01/2018; 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1