MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number ASKU

Device Problem Unintended Ejection (1234)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/02/2018

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 physician reported to the company representative that at the end of a cataract procedure a 30 gauge cannula shot off of the syringe and poked through the posterior capsule.He indicated the intraocular lens implant was in placed and he completed the procedure.No additional information is expected.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record and lot history could not be reviewed.The customer reported that their 30 gauge cannula shot off the syringe and went through the posterior capsule of the patient.The customer did not provide a lot number to review the device history record for a deviation, however there is an attachment in the file where the customer noted they had received a medline syringe as a deviation to their usual becton dickinson syringe.The root cause of the customer's complaint could not be established.Without a sample or details regarding lot/pak number, 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.Action will not be taken for this occurrence since a sample was not returned.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.Manufacturing management and quality engineering materials will be made aware of this complaint through the monthly complaint review meeting.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

It was identified the value was transmitted as null.This supplement is being filed to correct the value from null to adverse event and product problem.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 7817211
• MDR Text Key: 118252406
• Report Number: 1644019-2018-00212
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 30 GAUGE CANNULA; MEDLINE SYRINGE; 30 GAUGE CANNULA; MEDLINE SYRINGE
• Patient Outcome(s): Other; Disability
• Patient Age: 72 YR