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

Model Number VTICMO13.2

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But is not marketed in the u.S.Diopter: -17.00/+3.00/x093.Device evaluated by manufacturer? no, device not returned.(b)(4).Method: lens work order search.Results: a lens work order search revealed there were no similar complaints within the work order.Conclusions: conclusion not yet available.Evaluation is in progress.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2, -17.00/+3.00/x093 diopter implantable collamer lens in the patient's right eye (od).There was a fibre on the icl after inserting the lens into the eye.The lens was explanted and exchanged for another similar lens and size.This resolved the problem.

Manufacturer Narrative

(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5335403
• MDR Text Key: 34752574
• Report Number: 2023826-2015-01695
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• 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 Age: 25 YR