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

Model Number	BL5111
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Report 13 of 16.See 1920664-2017-00012, 00020, 00021, 00022, 00023, 00024, 00025, 00026, 00027, 00028, 00029, 00030, 00032, 00033, 00034.
Event or Problem Description
The surgeon has been seeing glimmering specks while irrigating the eye, and is not able to remove the particles.They are not sure what is causing the glimmer.Additional information: there have been no adverse effects, but the surgeon did confirm that he sees the ¿shimmer¿ indefinitely post-op.
Additional Manufacturer Narrative
Based on the results of our root cause investigation, it has been determined that the reported particulate is not related to any damage or malfunction of the product.Our investigation has concluded that the observed particles are originating from the metallic cap assembled to the needle wrench which when packaged in the same pouch with the silicone irrigation sleeve results in microscopic particles being transferred from the needle wrench cap to the irrigation sleeve.All products have been found to comply with specifications and function as intended.Additionally, there have been no reports of post-surgical adverse reaction.However, due to increased sightings of microscopic particles and our ongoing continuous improvement activities, we have taken measures to identify an internal cleaning process related to needle wrench assembly to address the reported events.Validation activities have been completed and the process has been implemented.In addition, we are reviewing our component specifications related to particulate matter and will revise specifications, where necessary to better align with customer expectations.As a result of this additional information, it has been determined that the issue documented in this report does not meet the criteria of a reportable malfunction and the complaint record will be revised accordingly.

• Brand Name: STELLARIS BASIC VACUUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6257779
• Report Number: 0001920664-2017-00031
• Device Sequence Number: 10872581
• Product Code: HQC
• UDI-Device Identifier: 10757770057099
• UDI-Public: (01)10757770057099(17)180213
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/13/2018
• Device Model Number: BL5111
• Device Lot Number: V7907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1