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

Catalog Number 8065601187

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

No sample or lot number information 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: (b)(4).

Event Description

A physician reported that ophthalmic oil was used during an unspecified ophthalmic surgery after which the patient experienced a hemorrhage, unspecified, with endophthalmitis.Additional information has been requested.

Manufacturer Narrative

No sample or lot code was provided.All compounding, preprocessing, filling and packaging mbrs are subjected to 2 independent reviews.Review of the incoming qc inspection results for the component lot codes is completed prior to disposition.The reported ophthalmic oil product is compounded by (1) chemical and thermal extraction and (2) sterile filtration of oil prior to filling.The product is then filled into its primary packaging components using aseptic processing.The reported product is filled into glass bottles and the stoppers are made from silicone.The product is terminally sterilized using dry heat.Following sterilization, units are 200% inspected for particulate in the solution and then packaged into pouches and sealed.Incoming components are verified to meet key design criteria via dimensional analysis and attribute inspection prior to disposition.The product insert includes the following precautions: do not use a vial for more than one patient.Discard unused portion.Do not admix with any other substances prior to injection.Do not re-sterilize.Do not use expired product.An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated iop.Caution must be exercised when using co2 laser in patients with a history of intraocular silicone oil placement.The root cause of the complaint condition cannot be determined.Potential root causes included: nonconforming unit ¿ no product lot code was provided for evaluation.Each lot is tested according to established specification prior to release for distribution.An event outside of the manufacturer's control - unable to determine.Lot specific evaluation is not possible without a lot code.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: 10937026
• MDR Text Key: 219296733
• Report Number: 1610287-2020-00035
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065601187
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other