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

Model Number VTICMO12.1

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

Patient Problem No Code Available (3191)

Event Date 08/14/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens in the patient's left eye (os) on (b)(6) 2014.The lens was explanted on (b)(6) 2014 due to low vaulting and lens rotation.The lens was exchanged for a longer lens and the problem was resolved.The patient's best-corrected visual acuity was 20/20.

Manufacturer Narrative

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

Manufacturer Narrative

Method: work order search, medical review.Results: a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found no visible damage to the lens.The lens was returned dry and there was evidence of clear surgical residue.Medical review - 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 ciliary sulcus or ciliary sulcus cyst).Several factors may contribute to rotation of an icl (i.E.Patients anatomical structure, a short lens, haptic position, etc.).Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, a probable root cause of inadequate 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 ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4361894
• MDR Text Key: 5112898
• Report Number: 2023826-2014-01152
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/25/2014

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: 12/31/2016
• Device Model Number: VTICMO12.1
• Other Device ID Number: DIOPTER -11.5/+2.5/77
• 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: 02/27/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR