MAUDE Adverse Event Report: BAUSCH + LOMB MICS SIL I/A HDP 45° STELL; UNIT, PHACOFRAGMENTATION

Model Number 85915ST

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/29/2023

Event Type  Injury  

Event Description

The user facility in the united kingdom reports that a split was identified in the tip of the ia handpiece following a cataract procedure that resulted in a posterior capsular rupture.Patient received an anterior vitrectomy.

Manufacturer Narrative

The product and particulate were discarded by the user and are unavailable for evaluation.The lot number was not recorded and not available therefore a lot history can not be provided.The investigation is ongoing.

Manufacturer Narrative

A sketch provided by the customer illustrating the damage to the silicone sleeve shows it occurred in an area that sometimes breaks when the needle is rubbing off the inner side of the sleeve.Due to the lack of sample or pictures, the issue that might have led to the incident could not verified and therefore, the root cause of the complaint could not be determined.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; im schuhmachergewann 4; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB GMBH; im schuhmachergewann 4; heidelberg 63122 ; GM 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17806473
• MDR Text Key: 324110297
• Report Number: 0001920664-2023-70090
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85915ST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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