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

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Event Description

The patient reported the surgeon implanted an micl implantable collamer lens in her right eye (od) over a month ago.The patient reported is now suffering from negative dysphotopsia.The patient has a constant darkness in the corner of the right eye.The right eye feels irritated and uncomfortable most of the time.The icl remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

This medwatch report has been filed 1 day late due to the fda gateway was unavailable in production due to technical problems on wednesday, (b)(4) 2014.The fda gateway was available in production as of thursday, (b)(4) 2014, 3:00 am edt.Pt age: unk.Pt weight: unk.Date of event: unk.Expiration date - unk.Implant date: unk.Explant date: unk (b)(4).Device evaluated by manufacturer? no.Lens implanted.(b)(4).Lens implanted.

Manufacturer Narrative

Method: medical review.Results: per medical review - reportedly, by a patient, one month after icl implantation she was diagnosed with negative dysphotopsia.According to the patient she was told by her doctor that issue would resolve on its own.Despite multiple attempts no additional information is obtained to date.Negative dysphotopsia is manifested as patient-reported observation of a dark crescent in the temporal field of the vision and they commonly state that the symptoms are similar to "wearing horse blinders".This condition is distinguished from positive dysphtotopsia which is characterized by undesired optical images.Negative disphotopsia is not induced by iols properties, but was most likely caused either by procedure related factors (incision placement, pharmacologic pupil construction and/or patient related factors (ocular anatomy, light sensation from temporal source, neuroadaptation) and generally symptoms remit after surgery without any additional medically intervention.(samuel masket ,md " pseudophakic negative dysphotopsia: surgical management and new theory of etiology" j cataract refract surg 2011;37:1199-1207).Conclusions: based on the complaint history, work order search and the medical review, the most likely cause of the event was either by procedure related factors (incision placement, pharmacologic pupil construction and/or patient related factors (ocular anatomy, light sensation from temporal source, neuroadaptation) and was not icl related.(b)(4).

Manufacturer Narrative

Conclusions: based on the complaint history and medical review, the most likely cause of the event was either by procedure related factors (incision placement, pharmacologic pupil construction) and/or patient related factors (ocular anatomy, light sensation from temporal source, neuroadaptation) and was not icl related.(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: 3812700
• MDR Text Key: 16797680
• Report Number: 2023826-2014-00356
• 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: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2014

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
• Other Device ID Number: DIOPTER UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/25/2014; 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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