MAUDE Adverse Event Report: Bausch + Lomb I/A HANDPIECE90° ANG.16G; Handheld Surgical Instrument

Model Number	85786ST
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in the united kingdom reported that during irrigation and aspiration a posterior capsule rupture (pcr) was noted.Additional information was requested.
Event or Problem Description
Additional information received: from memory, one patient required no anterior vitrectomy but sulcus lens was used.
Additional Manufacturer Narrative
The product is not available for evaluation and the 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.
Additional Manufacturer Narrative
The patient had no need for a vitrectomy, but a sulcus lens was used.This event was downgraded to not serious.

• Brand Name: I/A HANDPIECE90° ANG.16G
• Common Device Name: Handheld Surgical Instrument
• Manufacturer (Section D): Bausch + Lomb; eppelheim 69214 ; GM 69214
• Manufacturer (Section G): Bausch + Lomb GMBH; lilienthalstr.16.18; eppelheim 69214 ; GM 69214
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; +1(636)226-3089
• MDR Report Key: 50587115
• Report Number: 0001920664-2026-00071
• Device Sequence Number: 9586773
• Product Code: HNN
• UDI-Device Identifier: 24058935000114
• UDI-Public: (01)24058935000114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 85786ST
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown