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

Model Number VICMO12.1

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

Patient Problems Loss of Vision (2139); No Code Available (3191)

Event Date 11/10/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens in the patient's right eye (od) on (b)(6) /2014.The reporter indicated the lens had a low vault and there was loss of best-corrected visual acuity.The surgeon is planning on explanting the lens and exchanging for a longer lens.The lens remains implanted.The patient's current post-op best-corrected visual acuity is 20/30.

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 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 - 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, etc).Staar recommends the icl to be left implanted if no cataracts are noted or in cases where there is a trace anterior subcapsular cataract with no progression.Staar believes that the action to remove and/or replace the icl increases the risk for anterior subcapsular cataract.Based on the complaint history, work order search and medical review, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

(b)(4).Visual inspection of the returned product found one haptic torn.The lens was returned in liquid and there was evidence of clear surgical residue.The lens was rehydrated in bss for re-measurement.The lens length was measured and the result of the measurement was compared against the original value and the lens was found to be in specification.Based on the complaint history, work order search, medical review and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Event Description

Additional information received - the lens was explanted in the last week of (b)(6) 2015 and was exchanged for a longer lens.The problem was resolved.

• 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: 4362751
• MDR Text Key: 5292139
• Report Number: 2023826-2014-01159
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• 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,Followup,Followup
• Report Date: 12/08/2014

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: 02/28/2017
• Device Model Number: VICMO12.1
• Other Device ID Number: DIOPTER -14.00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/17/2015; 12/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• 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: 25 YR