MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN TICL (IMPLANTABLE COLLAMER LENS); INTROCULAR LENS

Model Number VTICMO13.2

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 07/23/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm13.2 implantable collamer lens on in patient's right eye.The physician performed secondary intervention, induced mydriasis and repositioned the lens.The patient last visit on (b)(6) 2014 - bcva: 20/40.The lens remains implanted.

Manufacturer Narrative

(b)(4): evaluation: method - work order search.Results - a lens work order search was performed and no similar complaints were found within the work order.Conclusions - (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4): the lens remains implanted.

Manufacturer Narrative

Method: medical review, device history record review.Results: medical review - according to use fmea (failure modes and effect analysis) it has been determined that excessive 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 ciliary sulcus or ciliary sulcus cyst).Abnormal anatomy of the posterior iris/ciliary body/zonules complex would interfere with normal positioning of the icl footplates.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.Conclusions: based on the complaint history, work order search, device history record review and the medical review, a probable root cause of excessive vaulting has been determined to be related to the inaccuracy of the white to white measurement or a mismatch between white to white and the sulcus to sulcus diameter.(b)(4).

• Brand Name: VISIAN TICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTROCULAR 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4123495
• MDR Text Key: 4948570
• Report Number: 2023826-2014-00760
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 08/29/2014

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: 10/31/2016
• Device Model Number: VTICMO13.2
• Other Device ID Number: DIOPTER -13.5/+2.0/087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 09/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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
• Treatment: INJECTOR MODEL AND LOT NUMBER - UNK; CARTRIDGE MODEL AND LOT NUMBER - UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR