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

Model Number VTICM13.7

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Halo (2227); No Code Available (3191)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticmo13.7 implantable collamer lens, -11.00/+3.5/123 diopter, in the patient's right eye (od) on (b)(6) 2016.The patient experienced a pupil block, with elevated intraocular pressure, unreactive pupil (fixed), glare/halos and blurred vision.The surgeon enlarged/addition the peripheral iridotomies (yag) and added a suture.The lens remains implanted.The patient's post-op best-corrected visual acuity was 20/20 -1 and the patient has photophobia.

Manufacturer Narrative

(b)(4): improper or incorrect procedure or method - the surgeon realized that the implanted icl model required preoperative peripheral iridotomies but he failed to do it due to confusion with the icl model ordered.Correction: from "13.7mm vticmo13.7" to "13.7mm vticm13.7".(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5766297
• MDR Text Key: 48683166
• Report Number: 2023826-2016-00871
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/06/2016

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: 06/30/2018
• Device Model Number: VTICM13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• 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 Outcome(s): Other
• Patient Age: 34 YR