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

Model Number VTICMO13.2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cataract (1766)

Event Date 11/17/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.The reporter indicated the patient has an anterior subcapsular opacity.The lens remains implanted.The opacity has decreased slightly after treatment steroid.The patient is being monitored.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4) - cataract, induced; (lens implanted).Device evaluated by manufacturer? no.Lens remains implanted.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).Lens implanted.

Manufacturer Narrative

Medical review - review of the file indicates that the lens was not implanted in accordance with the dfu requirements (e.G.Patient age below 21 or over 45 years, acd below 2.8mm for icl/ticl and below 3.0mm for vicl/vticl, keratoconus, pregnant or nursing patients, patients with low/abnormal corneal endothelial cell density, fuchs dystrophy or other corneal pathology, patients who are amblyopic or blind in the fellow eye).Off-label use of the device, no clinical data can support the complaint event(s) or the effect(s) on the efficacy and safety of the device.This information has been communicated to the medical advisor of staar surgical and to the surgeon in case of severe deterioration of patient health.Based on the complaint history, work order search and medical review, 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; 1911 walker ave; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4362772
• MDR Text Key: 16853197
• Report Number: 2023826-2014-01158
• 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: 12/05/2014

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: 08/31/2017
• Device Model Number: VTICMO13.2
• Other Device ID Number: DIOPTER -11.0/+3.5/093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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 Age: 27 YR