MAUDE Adverse Event Report: BAUSCH + LOMB GMBH SIL. COATED I/A 45 MIL 1/B; UNIT, PHACOFRAGMENTATION

Model Number	85910S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product sample was discarded on site by the customer.Due to the date of the event the customer was unable to identify the exact product used.Although requested, the lot number was not provided, therefore the udi-pi is not available.The device history record could not be reviewed because the lot number was not specified.Photos of the instrument were not provided, either.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.The investigation is complete.
Event or Problem Description
The user facility reported that that they had an issue in the past with the metal aspiration tube coming out of the irrigation hole in the handpiece, causing a capsule bag break.They did not realize it until after the main usage when they went back into remove viscoelastic.This event was from a couple years ago and it was just learned about.The date of event was not available.The doctor remembers that there was no significant delay, no additional anesthesia required, and that the patient was "fine".No further details are available.

• Brand Name: SIL. COATED I/A 45 MIL 1/B
• 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; saint louis, MO 63122 ; 6362263089
• MDR Report Key: 24719785
• Report Number: 0001920664-2026-00028
• Device Sequence Number: 12272164
• Product Code: HQC
• UDI-Device Identifier: 04058935000356
• UDI-Public: 04058935000356
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 85910S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown