MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS BASIC VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5111
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Eye Injury (1845); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product has been requested for evaluation however it has not been received.Sterilization and lot history records were reviewed and no exceptions were found.The investigation is ongoing.
Event or Problem Description
During a cataract procedure the irrigation flow was slow and only dripping.The doctor suspects blockage within the irrigation system.The capsule was ruptured and a vitrectomy was performed.
Additional Manufacturer Narrative
One opened bl5111 pack from lot number w1374 was received.Visual inspection found the assembly dirty with fluid in the lines and collection cassette.A functional test was performed using a stellaris pc system.The collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test, primed, irrigated and aspirated as intended.The assembly was not blocked.Product evaluation did not confirm the failure mode.Review of the complaint database revealed no other complaints have been submitted against lot w1374.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STELLARIS BASIC VACUUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7700661
• Report Number: 0001920664-2018-00087
• Device Sequence Number: 13702062
• Product Code: HQC
• UDI-Device Identifier: 10757770057099
• UDI-Public: (01)10757770057099(17)190812
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2019
• Device Model Number: BL5111
• Device Lot Number: W1374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention