MAUDE Adverse Event Report: BAUSCH + LOMB SILICONE COATED I/A 45° MILL.12/BX; HAN

Model Number 85910S

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

The sterilization and lot history records were reviewed and found to be acceptable.The customer has reported the product is not available for return.

Event Description

Reported patient underwent routine phaco surgery using the stellaris with the b&l i/a handpiece.A tiny fleck of metal has been seen post-op in the corneal incision on day 1.To date, the particle has not been removed from the eye.

• Brand Name: SILICONE COATED I/A 45° MILL.12/BX
• Type of Device: HAN
• Manufacturer (Section D): BAUSCH + LOMB; heidelburg ; GM
• Manufacturer (Section G): BAUSCH + LOMB; im schuhmachergewann 4; heidelberg 69123 ; GM 69123
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 949398-569
• MDR Report Key: 5851231
• MDR Text Key: 51295502
• Report Number: 0001920664-2016-00256
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 85910S
• Device Lot Number: FS16021891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 63 YR