MAUDE Adverse Event Report: BAUSCH + LOMB GMBH CAPSULEGUARD IA HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 85910S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Inflammation (1932); Toxicity (2333)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

The product was scrapped by the customer along with the other materials used during surgery.A lot number was not provided; therefore the sterilization and lot history records could not be reviewed.The internal, systematic microbiological monitoring of the product after manufacturing shows the endotoxin levels within specification.Based on the limited information available and the unavailability of the sample for testing, the cause of the complaint cannot 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.(report 3 of 3; see also 0001920664-2020-00173 & 0001920664-2020-00174).

Event Description

A user facility in (b)(6) reported three recent cases in which toxic anterior segment syndrome (tass) occurred.The territory manager called the surgeon multiple times as directed, but received no answer.No additional information is available.

• Brand Name: CAPSULEGUARD IA HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB GMBH; heidelberg 69123 ; GM 69123
• Manufacturer (Section G): BAUSCH + LOMB, GMBH; im schuhmachergewann 4; heidelberg 63912 3; GM 639123
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 11061340
• MDR Text Key: 223444367
• Report Number: 0001920664-2020-00175
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: K073023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2020

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: No Information
• Device Model Number: 85910S
• Device Catalogue Number: 85910S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention