MAUDE Adverse Event Report: ALCON - BELGIUM/ALCON N.V. CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Retinal Detachment (2047); Retinal Tear (2050); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 01/22/2015

Event Type  Injury  

Event Description

A customer reported that the cannula dissociated from the luer lock at the syringe while hydrating the incision site at the end of a cataract surgery.The cannula penetrated the eye, dislocated the newly implanted intraocular lens and ruptured the capsular bag.An emergency vitrectomy was performed that was complicated with a retinal tear and retinal detachment.Add'l info has been requested but not received to date.

Manufacturer Narrative

A sample is in transit to the manufacturing site for investigation.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 info becomes available.Add'l info has been requested but not received to date.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - BELGIUM/ALCON N.V.; medialaan 36; vilvoorde B-180 0; BE B-1800
• Manufacturer (Section G): ALCON - BELGIUM/ALCON N.V.; medialaan 36; vilvoorde B-18 00; BE B-1800
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4530278
• MDR Text Key: 20778478
• Report Number: 3002037047-2015-00045
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 406680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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
• Treatment: BVI VISITIEC RYCROFT CANNULA 30G; BECTON DICKINSON-BENELUX 3ML SYRINGE
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR