MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number 8065751593

Device Problems Energy Output Problem (1431); Failure to Power Up (1476); Noise, Audible (3273)

Patient Problem Retinal Injury (2048)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

A customer reported that during a procedure to repair a large retinal tear with a significant amount of lattice, in the left eye, the laser probe seemed to loose power and the light source and aiming beam became very dim.A second laser probe was used and there was difficulty getting a laser burn.The surgeon had to increase the laser output higher than he typically uses, as a result, a "pop" was heard and a large bubble was created.Once the bubble went away, it was observed that the laser burn had caused a focal destruction of the retina, rpe, and choroid so that the bare sclera was likely visible.There was no bleeding and the spot was fairly small and anterior.The surgeon was able to put normal burns around it.He continued to use the second probe, but then the light and aiming beam became dim.A third laser probe was used to complete the case without further incident.This is the first of two reports as it is unknown which lot was associated with the second probe.

Manufacturer Narrative

A 25 gauge illuminated flex curved laser probe was received for an evaluation.Visual assessment of the returned sample showed no obvious non-conformities.The sample was tested and met all product specifications.It should be noted that a laser output test is performed during manufacturing per the manufacturing assembly procedure (map) to verify that the laser beam outputs properly and within power specification.The sample was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The operator¿s manual includes warnings: before each use, visually inspect the outer surface of the distal tip of the fiber optic illuminator probe that will be inserted into the patient to ensure that there are no unintended foreign materials, rough surfaces, sharp edges, or protrusions, which may cause patient injury.Potentially hazardous radiated light is transmitted from the fiber optic illuminator probe.Refer to section one: retina risk factors to consider during operation of the ahbi (xenon light module) for advice on how to minimize the effects of the light intensity used.Illuminator probes are for single-use only.Potential risk from reuse or reprocessing illuminator probes labeled for single use include: phototoxicity from inconsistent laser or illumination exposure caused by a damaged fiber or connector, reduced laser/illumination output, fluid path leaks or obstruction resulting in reduced fluidics performance, and foreign particle introduction into the eye.The customer did not request service for the system and the consumables were not returned for evaluation.The cause of the photochemical light damage reported cannot be determined.The laser probe was packaged on august 2, 2018.There were (b)(4) paks associated with this lot.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: LASER PROBES
• Type of Device: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8418896
• MDR Text Key: 138757979
• Report Number: 2028159-2019-00417
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• PMA/PMN Number: K946135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 8065751593
• Device Lot Number: 18027758X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM XT
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR