MAUDE Adverse Event Report: BAUSCH + LOMB 25GAPOST PK W AFI&FF; UNIT, PHACOFRAGMENTATION

Model Number	BL5425W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The user facility in taiwan reported part of the cannula broke when the doctor tried to remove the trocar.The doctor inferred the broken part may have been stuck in the wall of the patient's eye, hence, he tried to enlarge the incision to find it.The doctor sheared conjunctiva and the wound, but he couldn't find the broken cannula from wound and posterior chamber in end.Suture was used to close the wound.The cannula may still be at the sclera.Additional information: the doctor did not arrange x-ray exam, he just used ophthalmoscope to try to find the cannula.The product was not found in the patient's eye.They will keep the patient under observation to see if there is any uncomfortable complaint.He didn't think the second surgery is necessary.The product is not available because the doctor had thrown it away.

• Brand Name: 25GAPOST PK W AFI&FF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6689732
• Report Number: 0001920664-2017-00239
• Device Sequence Number: 45695
• Product Code: HQC
• UDI-Device Identifier: 20757770058154
• UDI-Public: (01)20757770058154(17)180318
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101325
• 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
• Report Date (Section B): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 03/18/2018
• Device Model Number: BL5425W
• Device Lot Number: V8143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention