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

Model Number VICMO13.2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Anxiety (2328); No Code Available (3191)

Event Date 04/13/2015

Event Type  Injury  

Event Description

The reporter indicated the surgeon inserted the 13.2mm vicmo13.2 implantable collamer lens in the patient's left (os) eye on (b)(6) 2014 and on (b)(6) 2015 the patient was experiencing headaches, anxiety and insomnia.The lens was explanted on (b)(6) 2015 and was not replaced.See mfr report# 2023826-2015-00990 for the other eye.

Manufacturer Narrative

This product is manufactured in (b)(4) and is not marketed in the u.S.(b)(4).Method - work order search, device history record review.Results - a lens work order search was performed and no similar complaints were found within the work order.Conclusion - based on the complaint information and work order search, we are unable to determine a specific root cause of the event.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4957478
• MDR Text Key: 6037933
• Report Number: 2023826-2015-00991
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• 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
• Report Date: 07/08/2015

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: 04/30/2017
• Device Model Number: VICMO13.2
• Other Device ID Number: DIOPTER -10.50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2014
• 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: 41 YR