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

Catalog Number 8065103220

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

Patient Problems Corneal Abrasion (1789); Pain (1994); Discomfort (2330)

Event Date 02/18/2017

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 a patient experienced a corneal epithelial tear when sticking down the drape.The issue caused no delay to the procedure, but postoperative discomfort and pain.The patient was treated with a steroid and an antibiotic and is recovering slowly.The sample is not available for evaluation.

Manufacturer Narrative

The lot specific to this event is not known; therefore, lot history and device history record reviews are not possible.A sample has not been returned; therefore, the condition of the product could not be verified.The root cause of the customer's complaint is not known; a sample was not returned for investigation.Based on the information provided by the customer, the most likely root cause of this complaint is an error that occurred during the supplier's manufacturing process.Another potential root cause is the technique that is used to remove the drape.Action will not be taken for this occurrence as the root cause is not known.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.(b)(4).

• Brand Name: EYE-PAK OPHTHALMIC DRAPE
• Type of Device: DRAPE, PATIENT, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6471440
• MDR Text Key: 72083525
• Report Number: 1644019-2017-00326
• Device Sequence Number: 1
• Product Code: HMT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K830822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065103220
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• 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): Required Intervention
• Patient Age: 69 YR