MAUDE Adverse Event Report: ALCON PRECISION DEVICE - SINKING SPRING CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 04/17/2014

Event Type  Injury  

Event Description

A clinical director reported that a cannula detached form a syringe while hydrating during surgery causing a posterior capsule tear.The intraocular lens had to be explanted and a vitrectomy had to be performed.Additional information has been requested.

Manufacturer Narrative

Samples have been received by manufacturing that have not yet been evaluated.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.Additional information has been requested.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON PRECISION DEVICE - SINKING SPRING; 714 columbia ave; sinking spring PA 19608
• Manufacturer (Section G): ALCON PRECISION DEVICE - SNIKING SPRING; 714 columbia ave; sinking spring PA 19608
• Manufacturer Contact: janet moran ; 6201 south freway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3827861
• MDR Text Key: 4452820
• Report Number: 1644019-2014-00086
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CC SYRINGE; DISCOVISC
• Patient Age: 72 YR