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

Model Number VTICMO12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problems Cataract (1766); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); No Code Available (3191)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the switzerland but not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, 12.5/+2.00/03 diopter, in the patient's left eye (os) on (b)(6) 2014.The lens was explanted on (b)(6) 2016 due to lens rotation (not associated with low vaulting), lens opacity, lens dislocation/subluxation, refractive change over time and blurred vision.The lens was exchanged for a longer lens and surgeon repositioned the new lens.The patient's post-op best corrected visual acuity was 20/30.

Manufacturer Narrative

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, 12.5/+2.00/03 diopter, in the patient's left eye (os) on (b)(6) 2014.The lens was explanted on (b)(6) 2016 due to lens rotation (not associated with low vaulting), lens opacity, lens dislocation/subluxation, refractive change over time and blurred vision.The surgeon exchanged the lens for a longer lens and repositioned the lens and the problem was resolved.The patient's post-op best corrected visual acuity was 20/30.(b)(4).

Manufacturer Narrative

Device evaluation: the lens was returned in liquid, in lens case/vial.Visual inspection found no visible damage to the lens.Dimensional and functional inspection found the lens to be within specifications.(b)(4).Work order search: no similar complaints were reported for units within the same lot.Corrected data: the reporter indicated that the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -12.5/2.0/103 diopter, in the patient's left eye (os) on (b)(6) 2014.The lens was explanted on (b)(6) 2016 due to lens rotation not associated to a low vault, lens opacity, lens dislocation/subluxation, and blurred vision.Repositioning of the lens was performed and the lens was exchanged for a longer lens.The problem was resolved.The patient's post-op best corrected visual acuity was 20/30 and uncorrected visual acuity (ucva) was 20/30.(b)(4).

Manufacturer Narrative

The reporter stated that the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -12.5/2.0/103 diopter, in the patient's left eye (os) on (b)(6) 2014.The patient experienced lens rotation, dislocation, refractive change, and blurred vision.The surgeon repositioned the lens and the problem was resolved.On (b)(6) 2016, the surgeon reported lens opacity (asco) and low vault.The lens was exchanged for a longer lens on (b)(6) 2016 and the problem was resolved.The patient's post-op best corrected visual acuity was 20/30 and uncorrected visual acuity (ucva) was 20/30.Claim #(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6129538
• MDR Text Key: 60942929
• Report Number: 2023826-2016-01682
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2016

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: 11/30/2016
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/29/2016; 06/05/2017; 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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: 22 YR