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

Model Number	85915ST
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	08/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return.This investigation is ongoing.
Event or Problem Description
The user facility in the united kingdom reported a patient developed an infection in their eye and diagnosed with endophthalmitis.Medical intervention: post operation medication.
Event or Problem Description
Patients symptoms were pain, redness and hazy cornea.The patient was seen at (b)(6) on a monday and then referred to (b)(6) infirmary ((b)(6)) on the same day.The patient was discharged from (b)(6) but still requires follow up appointments.(b)(6) infirmary handled the patient medication treatment.Result of lab culture ¿ endophthalmitis (pseudomonas).
Additional Manufacturer Narrative
B5 - b7 additional information.The associated dhr of the sample involved in this complaint could not be reviewed as the lot no.Was not provided by the customer.Due to the lack of sample as well as additional information, the reported problem could not be verified and thus, the root cause of the complaint could not be determined.It is unclear how the customer developed the infection and was diagnosed with endophthalmitis.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
Correction: d1 manufactures city, state, postal code, and country.G site city.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; im schuhmachergewann 4; heidelberg NY 69123 ; GM 69123
• Manufacturer (Section G): BAUSCH + LOMB, INC.; im schuhmachergewann 4; heidelberg 69123 ; GM 69123
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17838556
• Report Number: 0001920664-2023-70095
• Device Sequence Number: 12686657
• Product Code: HQC
• UDI-Device Identifier: 04058935000516
• UDI-Public: (01)04058935000516
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2023

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
• 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: Not provided; Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/23/2023; 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BSS AND (B)(6).; STELLARIS UNIT, ACCESSORIES, AND BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown