MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number BL5325WV

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

The device was not available to be returned for evaluation.A review of the device history records found that the lot was manufactured using specified materials and that all assembly, inspection, and packaging steps were performed according to procedure by trained personnel.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.(report 1 of 3; see also (b)(4) & (b)(4)) on (b)(6) 2021, bausch + lomb received an email from sheila connors at cdrh/food and drug administration notifying the company that the report initially submitted on 03/12/2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

A user facility in china reported that, during surgery, the metal tip of the vitrectomy cutter detached and fell into the patient's eye.The metal foreign body was removed from the patient's eye and the operation continued.Two additional packs were opened and combined to complete the operation.The surgery was prolonged approximately two hours but no additional anesthesia was required.No medical intervention or treatment was required and the patient was discharged from the hospital.

• Brand Name: 25 GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122
• MDR Report Key: 11574780
• MDR Text Key: 249124149
• Report Number: 0001920664-2021-00024
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2021

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/11/2021
• Device Model Number: BL5325WV
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR