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

Model Number VTICMO12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/01/2013

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens in the patient's left eye (os) on (b)(6) 2013.The lens has a low vault and a refractive surprise.The lens remains implanted.The surgeon is planning on explanting and exchanging the lens for a longer lens.

Manufacturer Narrative

This product is manufactured in (b)(4) and is not marketed in the u.S.Pt weight: unk.Explant date: na.(b)(4).Device evaluated by manufacturer? no.Lens remains implanted.(b)(4).Lens implanted.

Manufacturer Narrative

A lens work order search was performed and no similar complaints were found within the work order.Medical review - clinical studies have shown that toric icl rotation occurs in (b)(4) of patients where a ticl has been implanted.Several factors may contribute to this phenomenon (i.E.Patients anatomical structure, a short lens, haptic position, etc.).Several factors may be involved in a post-operative refractive surprise, including inappropriate refractive surgical planning, a wrong lens calculation/selection, preoperative inaccurate determination of the eye's measurements to determine the power of the icl, induced refractive change by incisions, unstable cornea and/or refraction prior to implantation, cl-induced warpage, upside-down lens, etc.According to use fmea (failure modes and effect analysis) it has been determined that inadequate vaulting is a consequence of a wrong lens use failure mode (i.E.Improper white to white measurement, variability of the white to white measurements based upon different techniques utilized, improper sulcus to sulcus measurement (if ubm used), and patient condition; poor correlation of white to white measurement and length of ciliary sulcus in an individual case; irregular sulcus or ciliary sulcus cyst).A review of the device history record was performed and nothing was found in the manufacturing process of this lens that was the root cause of the complaint.Based on the complaint history, work order search, medical review and the device history record reviewt, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4362749
• MDR Text Key: 5263541
• Report Number: 2023826-2014-01157
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 12/03/2014

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: 07/31/2015
• Device Model Number: VTICMO12.6
• Other Device ID Number: DIOPTER -9.5/+1.5/090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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 Age: 31 YR