MAUDE Adverse Event Report: ALCON LABORATORIES, INC. PERFLUORON; FLUID, INTRAOCULAR

Catalog Number 8065900111

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Retinal Detachment (2047)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

No sample or confirmed lot number has been received by manufacturing for evaluation.Four possible lot numbers have been reported.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.Additional information has been requested.The manufacturer internal reference number is: 2017-32909.

Event Description

A surgeon reported retinotoxicity after ophthalmic device liquid was instilled into the right eye of a patient during vitreoretinal surgery on (b)(6) 2017.The patient was treated for rhegmatogenous retinal detachment without macular condition and vitreo hemorrhage.Upon ten day postoperative examination, the affected eye was diagnosed with potential retinotoxicity.Additional information has been requested and received.Relevant test and lab data ((b)(6) 2017): va: light perception and projection in the 4 quadrants, iop: 22 mmhg.Anterior segment: subcapsular posterior paracentral nasal opacity.Eye fund: retina reapplied with adequate pexia at 2 and 7 o'clock.Pale papillae vascular tree attenuation.Image of macular pseudohole.Atrophique alteration of retina with speckled appearance in posterior pole.Fluorescein angiography: delay in arterial filling time.No perifoveal vascular arcade is detected.Lack of arborization of arterial vessels in certain segments.Generalized thinning of retinal vascular tree.Optical tomography of coherence: thinning of all layers of the retina with the disappearance of outer limiting membrane.

Manufacturer Narrative

No sample used in the mentioned surgery is available thus, no sample has been received by manufacturing for evaluation.The facility reported four possible lots: 266986f, 257576f, 266985f and 266984f and are not able to distinguish which lot was used in the affected surgery.The reported lots are for the kit which contains the 10cc syringe, 20ga needle, 0.2 micron filter, a product insert and the 5 ml perfluoro-n-octane liquid unit.A complaint history for the reported possible kit lots and their associated component lot codes was completed and no other complaints were reported.Review of the compounding, filling, blistering and packaging manufacturing batch records (mbrs) showed no anomalies that may have contributed to the complaint condition.No nonconfomances or deviates were noted in the mbrs.All finished product testing results met specifications.The product is manufactured according to requirements of the perfluoro-n-octane 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.The product insert provides indications, instructions and storage conditions.Customer product storage and use could not be confirmed.The product labeling for perfluoro-n-octane liquid provides indications for use, contraindications, warnings, precautions and directions for use to ensure proper use of the product.Instructions also state: ¿all components for single use only¿.The root cause could not be determined.Potential root causes include: - product nonconformance; however, this is unlikely based on the compounding and filling procedures that were performed as well as the finished product testing results.- nonconformance with the kit syringe, filter or cannula; however, the results of the incoming inspection met specifications for each of these components.- events outside of the manufacturing environment; however, this cannot be confirmed.A comprehensive review was performed including a review of the processes, complaint histories, batch record review, finished product testing results and incoming qc component inspection results.The review shows that the manufacturing processes were in a state of control.Based on the acceptable mbr reviews, incoming qc component inspection results, finished product test results and the lack of an adverse complaint trend for these lots, the reported possible lots continue to be acceptable.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received in a letter from the patient's attorney whereby it was stated that the patient has suffered a severe affectation in the conduction of the right pre-chiasmatic visual pathway, that is, an atrophy of the optic nerve without recovery, concluding as a diagnostic hypothesis the retinotoxicity by perfluorocarbon in her right eye.

Manufacturer Narrative

An intravitreal ocular safety evaluation of perfluoro-n-octane in rabbits was performed to evaluate the ocular irritation and inflammatory potential of different lots of purified perfluoro-n-octane liquid following a single intravitreal injection in new zealand white rabbits.In conclusion, there was no test article-related ocular irritation or inflammation observed following a single injection of four (4) different lots of the manufacturer's perfluoro-n-octane lot numbers 257576f, 266984f, 266985f and 266986f in new zealand white rabbits when observed for 48 hours.Additionally, an in vitro toxicity study of the manufacturer's perfluoro-n-octane product on cultures of human retinal pigment epithelial cells and porcine neuroretina was performed by ioba (instituto universitario de oftalmobiología aplicada).In conclusion, the product ¿pfo medical device¿ lot numbers 257576f, 266984f, 266985f and 266986f (a, b, c and d)* were provided by the manufacturer and tested with human rpe cell culture: ¿ lots 257576f, 266984f, 266985f and 266986f are non cytotoxic.It is concluded based on the differences in terms of viability compared to the controls used in the experiments performed following the une-en iso 10993-5:2009 ¿tests for in vitro cytotoxicity¿.The product ¿pfo medical device¿ lot numbers 257576f, 266984f, 266985f and 266986f (a, b, c and d)* were provided by the manufacturer and tested with porcine neuroretina culture: ¿ lots 257576f, 266984f, 266985f and 266986f are non cytotoxic.It is concluded based on the differences in terms of the cell/tissue degeneration compared to the controls used in the experiments performed following the une-en iso 10993-5:2009 ¿tests for in vitro cytotoxicity¿.Retinal toxicity from other possible causes outside of perfluoro-n-octane liquid during intraocular surgery have been identified in clinical literature and may manifest clinically in several ways, depending on the insulting agent.Generally, inadvertent (iatrogenic) injection of any substance or medication that is not compatible for intravitreal use will present with retinal toxicity.One good example is reported cases of intravitreal injection of aminoglycosides (antibiotics) in the intraocular cavity which typically present similarly to the reported case in this instance: severe vascular occlusion, and optic neuropathy.Other scenarios that could be considered in the differential diagnosis are factors that may present with the same clinical picture as retinal toxicity.¿ retinal vascular occlusion from anesthetic complications ¿ increased risk with utilization of retrobulbar anesthesia in instances where the optic nerve sheath is inadvertently injected with anesthetic ¿ inadvertent increase in intraocular pressure (iop) during surgery causing retinal vascular occlusion.Incidence with the use of inappropriate use of surgical equipment parameters and surgical tamponades has been well reported in clinical literature.¿ phototoxicity from the microscope or endoilluminator which present as white retinal lesions post-operatively.The wavelength of light used, the power of the light source and the duration of use determine the amount of ocular damage in phototoxicity ¿ patient inherent factors, such as pre-existing pathology, medications, etc.That may increase their susceptibility to toxicity from different etiologies.Available patient information and review of relevant clinical literature support the clinical presentation consistent with known causes of vascular occlusion associated with vitrectomy.A comprehensive review was performed including a review of the processes, complaint histories, batch record review, finished product testing results, and incoming qc component inspection results.The review shows that the manufacturing processes were in a state of control.Based on the acceptable manufacturing batch record (mbr) reviews, incoming qc component inspection results, finished product test results, and the lack of an adverse complaint trend for these lots, these lots continue to be acceptable.The manufacturer internal reference number is: (b)(4).

• Brand Name: PERFLUORON
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6519862
• MDR Text Key: 73624542
• Report Number: 1610287-2017-00035
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P950018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065900111
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR