MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number VICH12.6

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

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Event Description

The surgeon implanted a 12mm vich12.6 implantable collamer lens in the patient's right (od) eye and inadvertently touched the capsule.Consequently, patient experienced tramatic lens opacity.The ich was removed and a phaco iol was implanted.The customer reported the event was due to a surgeon's error.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Results: visual inspection of the returned product showed the lens was returned dry with no visible damage.Both the width and length were remeasured and found to be within original design specifications.Therefore, it can be justified that the complaint was not product related.(b)(4).

Manufacturer Narrative

A lens work order search was performed and there were no similar complaints found within the work order.Medical review indicates that the surgeon inadvertently broke the lens capsule while performing incisions for the icl implantation.The surgeon decided not to proceed with the icl and perform refractive lens exchange instead (phaco and iol implantation with trifocal lens).The cause of the event is traumatic episode due to surgeon's error while using the surgical blade; non-icl related.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4179306
• MDR Text Key: 5099647
• Report Number: 2023826-2014-00838
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: VICH12.6
• Other Device ID Number: DIOPTER +08.00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 10/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2014; 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR