MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON EYE-PAK OPHTHALMIC DRAPE; DRAPE, PATIENT, OPHTHALMIC

Catalog Number 8065103120

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 01/21/2020

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

Event Description

A patient reported the skin from the scalp and temple area was removed with the drape and she experienced episodes of sharp pain after undergoing a cataract extraction procedure on her left eye.The patient initially indicated she used cortisone cream and the issue resolved after ten days.Addition information from the patient was received.The patient indicated she applied a triple antibiotic ointment for weeks and the area healed completely with no scarring, no residual effects and no pain.No additional information is expected.This is one report of two for this patient.

Manufacturer Narrative

Additional information provided in h.6.And h.10.The customer did not retain the product lot information for this custom pak procedure pack, therefore the device history records traceable to the reported pack could not be reviewed.The customer reported "this is not a complaint against alcon." it was reported a drape removed skin from the patient's cheek.The drape reported originates from a supplier manufacturer.No sample has been returned for evaluation; therefore, the condition of the product could not be verified to suggest the root cause originated from the drape or operator error.When this type of issue occurs, a sample(or image) should be returned so that a root cause evaluation can be performed.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.The manufacturer internal reference number is: 2020-12742.

• Brand Name: EYE-PAK OPHTHALMIC DRAPE
• Type of Device: DRAPE, PATIENT, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 9848061
• MDR Text Key: 183932628
• Report Number: 1644019-2020-00151
• Device Sequence Number: 1
• Product Code: HMT
• Combination Product (y/n): N
• PMA/PMN Number: K830822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065103120
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEOSPORIN OINTMENT; NEOSPORIN OINTMENT
• Patient Outcome(s): Required Intervention