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

Model Number 85915ST

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Endophthalmitis (1835)

Event Date 08/19/2023

Event Type  Injury  

Manufacturer Narrative

The product is not available for return.This investigation is ongoing.

Event 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 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).

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.

Manufacturer Narrative

Correction: d1 manufactures city, state, postal code, and country.G site city.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Type of Device: 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
• MDR Text Key: 324525319
• Report Number: 0001920664-2023-70095
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 04058935000516
• UDI-Public: (01)04058935000516
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 85915ST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/23/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS AND (B)(6).; STELLARIS UNIT, ACCESSORIES, AND BSS.
• Patient Outcome(s): Required Intervention