MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT, PHACOFRAGMENTATION

Model Number BL5113

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the product is not available for return.The lot number is unknown.As such, a device history record review cannot be performed.Further investigation is underway.

Event Description

User facility in (b)(6) reported lack of rigidity of sleeves from pack bl5113.During surgery, there was difficulty to enter the eye as the sleeve got stuck at the incision site.There was no patient impact.

Manufacturer Narrative

The product remains unavailable for return and the lot number is still unknown.No further analysis can be performed.There are currently no open nonconformances for the issue of improper fit for the sleeves.The trend analysis, risk analysis, and directions for use review are considered acceptable, with the product performing within anticipated rates.We will continue to monitor complaints of this type.The investigation is complete.

• Brand Name: STELLARIS MICRO INCISION VACUUM PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman road; rochester NY 14609
• MDR Report Key: 7914768
• MDR Text Key: 122171672
• Report Number: 0001920664-2018-00126
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL5113
• Device Catalogue Number: BL5113
• Device Lot Number: UNKNOWN
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1