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); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 04/25/2015

Event Type  Injury  

Event Description

Reporter indicated that the surgeon implanted a 12.6 vticmo12.6 implantable collamer lens in to the patient's left eye (os) on (b)(6) 2014.Low vault and rotation of the lens were noted, the lens was exchanged for a longer lens on (b)(6) 2015 and the problem was resolved.Reference mfr.Report # 2023826-2015-00638 for patient's right eye.

Manufacturer Narrative

This product is manufactured in the u.S.But is not marketed in the u.S.(b)(4).Secondary surgery.New incision.Explanted.Vaulting.(b)(4).

Manufacturer Narrative

Method: lens work order search & medical review.Results: visual inspection of the returned product showed the lens was received dry with no visible damage observed.A lens work order search revealed there were no similar complaints within the work order.Medical review - according to use fmea (failure modes and effect analysis) it has been determined that the inadequate vault is a consequence of wrong lens use failure mode (i.E.Improper white to white measurements, 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, ect).Several factors may contribute to rotation of an icl (i.E.Patient's anatomical structure, a short lens, haptic position, etc.).Conclusion: based on the complaint information, work order search, medical review and evaluation of the returned product, a probable root cause of the inadequate vaulting has been determined to be related to inaccuracy of the white to white measurement or 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; 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: 4816518
• MDR Text Key: 19810540
• Report Number: 2023826-2015-00639
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

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: 05/31/2017
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: DIOPTER: -15.0/2.5/95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR