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

Model Number VTICMO13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Visual Disturbances (2140); No Code Available (3191)

Event Date 02/25/2014

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): na, this product is manufactured in the u.S.But not marketed in the u.S.Work order search: no additional similar complaint type events within associated lots were found.(b)(4).This is a resubmission of the initial mdr per fda request.

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens -13.5/+2.0/97 diopter, in the patient's right eye (od) on (b)(6) 2014.The patient experienced excessive vault, pupil block with elevated iop and refractive change over time.The patient's post-op best corrected visual acuity was 20/20.Patient lives outside of country and will arrange follow-up with surgeon.

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, 2560 ; SZ 2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, 2560 ; SZ 2560
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 3037902237
• MDR Report Key: 6541708
• MDR Text Key: 201334669
• Report Number: 2023826-2016-01557
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• 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: 10/18/2016

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 Expiration Date: 11/30/2016
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• 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