MAUDE Adverse Event Report: BAUSCH + LOMB VACUUM PHACO PACK WITH 2.2 MM 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	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.One small plastic specimen cup was returned in a plastic bag.The device was not received.The specimen cup contains two small white/translucent colored particles.The particles are hard to the touch.Both particles are approximately 80 u.The particles were sent to the lab for evaluation.The eds analysis indicated that the white colored particle consists primarily of carbon.Lesser concentrations of silicon, calcium, oxygen, aluminum, chlorine and sodium were also detected.This is consistent with organic material, mineral deposits and saline residue.The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The user facility reported a piece of plastic came out of the sleeve during the procedure.The doctor was unsure if it is coming from the sleeve.He used a utrata forceps to remove the foreign matter from the eye.No issue to the patient.

• Brand Name: VACUUM PHACO PACK WITH 2.2 MM SLEEVE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6689705
• Report Number: 0001920664-2017-00244
• Device Sequence Number: 13464319
• Product Code: HQC
• UDI-Device Identifier: 10757770058409
• UDI-Public: (01)10757770058409(17)181001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/14/2017

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: 10/01/2018
• Device Model Number: BLV3220000
• Device Lot Number: V9170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1