MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL5323W
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The trocar cannula broke while in the eye.Half of the cannula was removed from the eye and the other half fell into the vitreous.A second procedure was performed on (b)(6) 2017 to remove the foreign body from the eye.Additional information received states the surgeon reprocessed and reused the disposable product.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6417435
• Report Number: 0001920664-2017-00127
• Device Sequence Number: 10773634
• Product Code: HQC
• UDI-Device Identifier: 20757770058116
• UDI-Public: (01)20757770058116(17)170121
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: Physician
• Device Expiration Date: 01/21/2017
• Device Model Number: BL5323W
• Device Lot Number: V5339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention