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

Model Number VTICMO13.2

Device Problem Activation Failure (3270)

Patient Problems Cataract, Induced (1767); Blurred Vision (2137); No Code Available (3191)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Patient code (b)(4)-no code available (secondary surgery, lens exchange, phaco-emulsification).Lens work order search: no similar complaint types reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that after the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, diopter -10.5/+2.0/097 into the patient's left eye (os), the lens would not properly unfold.The surgeon states that, "after all possible maneuvers" the lens didn't unfold properly and the lens was explanted.During explant the lens was scratched.This occurred on (b)(6) 2017.Reportedly, the surgeon then peformed phaco-emulsification on the eye and implanted an exchange iol on (b)(6) 2017 "without complications.".

Manufacturer Narrative

Best corrected visual acuity (bcva), on (b)(6) 2017, was 20/30 which was a decrease from baseline bcva (20/25).(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6955552
• MDR Text Key: 89561229
• Report Number: 2023826-2017-01577
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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,Followup
• Report Date: 06/06/2017

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: 09/30/2017
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 12/04/2017; 01/03/2018
• Supplement Dates FDA Received: 12/04/2017; 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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: 33 YR