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

Model Number TICM120V4

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

Patient Problems Edema (1820); No Code Available (3191)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.0mm ticm120v4 implantable collamer lens, -13.5/+1.00/090 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to low vaulting.The lens was exchanged for a longer lens and the problem was resolved.The patient's post-op uncorrected visual acuity was 20/20.The patient had some mild wound edema post-op.

Manufacturer Narrative

It should be noted that at the time of the original implantation the patient was (b)(6) years old and per dfu indications: "visian® implantable collamer® lenses (vicl) are indicated for use in phakic eye treatments in adults 21-45 years of age", and therefore, there is no sufficient safety and effectiveness data to support implantation in such patients.Claim # (b)(4).

Manufacturer Narrative

Device evaluation: visual inspection of the returned product found no visible damage to the lens.The lens was returned dry and there was evidence of clear sticky residue on the lens.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6278117
• MDR Text Key: 65764146
• Report Number: 2023826-2017-00073
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

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: 12/31/2018
• Device Model Number: TICM120V4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2016
• 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: 53 YR