MAUDE Adverse Event Report: ALCON RESEARCH, LLC PERFLUORON; FLUID, INTRAOCULAR

Catalog Number ASKU

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

Patient Problems Ischemia (1942); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2020

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 heavy ophthalmic liquid was used during a retinal detachment surgery which, at one week post-op, the patient demonstrated visual field loss, decreased visual acuity and signs of ocular toxicity in the retinal cells which has not recovered four months later.Additional information has been requested.Additional information received further clarified that the heavy liquid product was fully removed from the patient's eye at the time of the surgery.There was no retention of the heavy liquid noted in the patient's eye after surgery.Additional information received further clarified the case as an uneventful vitrectomy procedure with heavy liquid to repair inferior macula on retinal detachment under local anesthesia after which sustained profound loss of vision was experienced that has not recovered after four months.Marked retinal and macular atrophy with arterial and venous occlusion was noted.The physician suspected heavy liquid toxicity.

Event Description

Additional information received further clarified that the ophthalmic heavy liquid was used first then removed completely from the patient's eye.Subsequently, ophthalmic gas was put into the eye at the end of the surgery.The patient was reported to have been compliant with the use of the ophthalmic gas.Laser power of 200mw with duration of 0.2 seconds was applied to the far peripheral retina.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

No sample or lot code was returned by the customer therefore, lot specific evaluation cannot be completed.All compounding, preprocessing, filling and packaging mbrs are subjected to 2 independent reviews.All chemistry and microbial finished product results.Environmental, utility, bioburden records, and sanitization records.At a minimum, a single normal level 1 particulate inspection is completed for each lot and a level i iba is performed for every lot manufactured.This product is terminally sterilized and all sterilization cycles are reviewed before product is released.Primary components are verified to meet release criteria prior to release to production.The product is manufactured according to requirements of the product's device master record.The product is sterilized via filtration through sterilized silastic tubing filled into the dry heat sterilized vials using a peristaltic pump.After setting up the pump fill volume target, the first 42 units are discarded.There are no other solutions or opportunity for other fluid to be introduced into the product vials.Finished product testing includes infrared adsorption, uf absorption, mnr, purity of the product by (gas chromatography), particulate analysis, bioburden and sterility.Testing must meet lot specifications prior to release.Per the product's directions for use (dfu), this ophthalmic heavy liquid, by virtue of its high specific gravity, functions as a mechanical tool during vitreoretinal surgery, providing hydrokinetic manipulation of the detached retina.This high specific gravity allows the heavy liquid to be infused over the posterior portion of the retina to facilitate retinal flattening and anterior displacement of sub retinal fluid.The product insert provides indications, instructions, and storage condition.Customer product storage and use could not be confirmed.Root cause could not be determined.Potential root causes include: solution quality issue unlikely, as chemistry and microbiology data as well as finished product testing was reviewed and was found to have met regulatory requirements prior to release.Event related to consumer physiology no conclusion can be made regarding the contribution of unique consumer physiology as this factor is outside the control of the manufacturing facility.Event outside of the manufacturer's control (product storage, use, and surgical practice); this could not be confirmed.Surgical technique, product handling and storage are unknown.Lot specific evaluation is not possible without the lot code being reported.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: PERFLUORON
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 11439065
• MDR Text Key: 238723629
• Report Number: 1610287-2021-00004
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• PMA/PMN Number: P950018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C3F8 GAS AT 12%; CEFOTAXIME; CHIROCAINE 0.5%; DEXAMETHASONE
• Patient Outcome(s): Other
• Patient Age: 53 YR