MAUDE Adverse Event Report: ALCON RESEARCH, LLC SILIKON 1000 OIL; FLUID, INTRAOCULAR

Catalog Number 8065601187

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: 2020-67478.

Event Description

A health professional reported that the oil bottle was broken within the packaging.The edges had broken through the packaging and cut the staff person's hand.Additional information has been requested.Additional information received clarified that the staff person received treatment in the form of pressure to their cut and a band-aid was applied.The current status of the staff person's cut was reported as healed.

Manufacturer Narrative

Review of the complaint history showed no similar complaint reported.Review of the preprocessing, filling and packaging manufacturing batch records (mbrs) showed no anomalies that may have contributed to the complaint condition.A single normal level 1 inspection by attributes for particulate inspection was completed by qa for this product met specifications.Incoming components are verified to meet key design criteria via dimensional analysis and attribute inspection prior to disposition.The root cause cannot be determined.Potential root causes that could be associated with the complaint condition include, but cannot be confirmed: nonconforming bottle- this is highly unlikely as the bottle undergoes several.Inspections from filling and packaging in process checks.In addition, the bottle is subjected to several processes that require handling of the bottle by packaging operators, unable to confirm.Customer handling-unable to confirm.Shipping damage outside of organization control.A comprehensive evaluation was completed that included review of the compliant history, mbrs, and finished product testing.The review shows that the manufacturing processes were in a state of control.Based on acceptable mbr reviews, in-process and finished product inspection results, the lot continue to be acceptable.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: SILIKON 1000 OIL
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 10995283
• MDR Text Key: 221219262
• Report Number: 1610287-2020-00036
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 8065601187
• Device Lot Number: 105RP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other