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

Model Number TICM125V4

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/25/2014

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in (b)(4), but not marketed in the u.S.(b)(4).Device not returned.

Event Description

The reporter indicated the surgeon implanted a 12.5mm ticm125v4, -19.50/1.50/x009 diopter implantable collamer lens in patient's right eye on (b)(6) 2014.Excessive vault with significant reduction of indo-corneal angles was noted.A repositioning of the lens was performed.The lens was explanted and exchanged for a shorter length lens on (b)(6) 2016.This resolved the problem.Patient's last visit on (b)(6) 2016, ucva was 20/33.See mfr.#2023826-2016-00714 for left eye.

Manufacturer Narrative

(b)(4).Change "indo-corneal angles" to "irido-corneal angles".(b)(4).

Manufacturer Narrative

Device evaluation: the lens was returned in liquid in lens case/vial.Visual inspection found the haptic broken.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5668415
• MDR Text Key: 45570600
• Report Number: 2023826-2016-00713
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/22/2016

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 Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: TICM125V4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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: 33 YR