MAUDE Adverse Event Report: BAUSCH & LOMB GMBH MICS SIL I/A HDP 45° STELL 12B; UNIT, PHACOFRAGMENTATION

Model Number	85915ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return.A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed.Due to the lack of sample and photos/videos, the reported problem could not be verified and therefore, the root cause of the capsule damage 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.
Event or Problem Description
The user facility in australia reported during the polishing portion of a cataract procedure, posterior capsule (pc) tear occurred.Due to the pc tear and the need for vitrectomy, surgery was extended by approximately 20 minutes, requiring extra topical anesthetic.No extra medications or treatments were needed.Patient was reviewed the following day, (b)(6) 2026, and no adverse outcomes were reported.

• Brand Name: MICS SIL I/A HDP 45° STELL 12B
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH & LOMB GMBH; im schuhmachergewann 4; heidelberg D-691 23; GM D-69123
• Manufacturer (Section G): BAUSCH & LOMB GMBH; im schuhmachergewann 4; heidelberg D-691 23; GM D-69123
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 24391095
• Report Number: 0001920664-2026-00017
• Device Sequence Number: 10504211
• Product Code: HQC
• UDI-Device Identifier: 04058935000516
• UDI-Public: (01)04058935000516
• Combination Product (Y/N): N
• PMA/510(K) Number: K951463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 85915ST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown