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

Model Number BL5525WV

Device Problem Difficult to Insert (1316)

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

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

A lot number was not provided; therefore the sterilization and lot history records could not be reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.

Event Description

The user facility in (b)(6) reported the infusion cannula could not be inserted into a valved cannula.It was replaced with another product and the surgery was completed.No patient injury reported.

• Brand Name: 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI &WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 7683586
• MDR Text Key: 113892047
• Report Number: 0001920664-2018-00076
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL5525WV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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