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

Model Number MICL 12.6

Device Problem Insufficient Information (3190)

Patient Problems Vitreous Floaters (1866); No Code Available (3191)

Event Type  Injury  

Event Description

The patient reported the surgeon implanted a 12.6mm micl 12.6 implantable collamer lens in her right eye (od) on (b)(6) 2008.The patient reported vision is not as clear, has a lot of floaters.The icl remains implanted.The surgeon indicated the patient had a mild refractive error and felt the event was not related to the device.The event had a duration of 12 months or more.No medications or treatment was required.The patient's post-op visual acuity was 20/25.

Manufacturer Narrative

(b)(4) - (vision not as clear); vitreous floaters; (mild refractive error).Device evaluated by manufacturer? no.Lens 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).

Manufacturer Narrative

Method: medical review.Results: per medical review - a (b)(6) patient reported changes in visual clarity ("floaters") following icl implantation in 2008.According to the dcr, dated on 2/17/14, the symptoms were caused by mild refractive error and not associated with the device.It should be noted that the surgeon targeted myopic outcome for os ( mono vision) during the initial surgery and that could have also contributed to the reported event.The spectacles (presumably presbyopic ) were suggested for correction of refractive error.No additional intervention was planned or performed and va was 20/20.The need for glasses does not constitute a serious injury.Conclusions: based on the complaint history, work order search and the medical review, the symptoms were caused by mild refractive error and not associated with the device.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3675963
• MDR Text Key: 20661003
• Report Number: 2023826-2014-00198
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

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: 10/31/2009
• Device Model Number: MICL 12.6
• Other Device ID Number: DIOPTER -12.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2007
• 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 Age: 43 YR