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

Model Number 85915ST

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problem Capsular Bag Tear (2639)

Event Date 10/16/2023

Event Type  Injury  

Event Description

A user facility in the united kingdom reported that during surgery the sleeve is collapsing and sticking the inner aspiration tube at the corneal incision site.There was a sudden advancement and a posterior capsule rupture occurred during irrigation and aspiration.The procedure was changed and a vitrectomy was performed on the patients eye.Surgery was increased 15-30 minutes.

Manufacturer Narrative

Product has not been received for evaluation.Review of manufacturing and sterilization records, trend analysis, risk assessment, and directions for use is underway.The investigation is ongoing.

Manufacturer Narrative

Evaluation of a photo of the product revealed the sleeve looks flimsy and thin making it harder for the needle to move during surgery.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.With all available information root cause was determined to be lack of a drying/tempering process.The investigation is ongoing.

Manufacturer Narrative

Evaluation of a photo of the product revealed the sleeve looks flimsy and thin making it harder for the needle to move during surgery.Product was evaluated and confirmed the findings, the sleeve is flimsy and thin.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.With all available information root cause was determined to be lack of a drying/tempering process.The investigation is completed.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Type of Device: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; im schuhmachergewann 4; heidelberg ; GM
• Manufacturer (Section G): BAUSCH & LOMB GMBH; im schuhmachergewann 4; heidelberg ; GM
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18122154
• MDR Text Key: 327992415
• Report Number: 0001920664-2023-70126
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 24058935000367
• UDI-Public: (01)24058935000367(10)FS23091305(17)260804
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/16/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: FS23091305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2024; 03/22/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention