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

Model Number VTICMO13.7

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

Patient Problem No Code Available (3191)

Event Date 11/08/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticmo13.7 implantable collamer lens in the patient's right eye (od) on (b)(4) 2014 and excessive vault was noted.The lens remains implanted and the surgeon plans to exchange it for a smaller lens.

Manufacturer Narrative

This product is manufactured in the u.S but not marketed in the u.S.Pt age: date of birth - unk.Pt weight: unk.(b)(4).Method: work order search, medical review.Results: a lens work order search was performed and no similar complaints were found within the work order.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.Conclusions: (no conclusion can be drawn): based on the complaint history, medical review and work order search, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: VISIAN TICL (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: 4367391
• MDR Text Key: 5111342
• Report Number: 2023826-2014-01161
• 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
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: VTICMO13.7
• Other Device ID Number: DIOPTER -0.2 40029 1.03
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2014
• 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 Age: 44 YR