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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); No Code Available (3191)

Event Type  Injury  

Event Description

The patient reported through (b)(6) she had an icl implanted in her left eye (os).At one day post-op she was having a hazy blurry effect.The patient reported her physician indicated her vision was 20/40 and there was some swelling in her eye.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

(b)(4): device evaluated by manufacturer? no - lens implanted.(b)(4).

Manufacturer Narrative

Per medical review - the patient reported that she was experiencing subjective visual disturbances ("blurry", "hazy" vision) following micl implantation one day after implantation.It should be noted that she compared visual clarity in this eye with excellent visual clarity of the fellow eye that was implanted earlier with icl.She was told by her doctor that there was some "swelling" and that va was 20/40.The lens remains implanted.The reassessment will be performed when (if) additional information is received from the implanting surgeon.It should be noted that subjective visual disturbances ("glare/halos") have been identified as potential complications after icl implantation.The optical diameter of the icl ranges from 4.9 mm to 5.8 mm and the precautions section of the dfu instructs physicians that "prior to surgery, the surgeon must provide prospective patients with a copy of the patient information booklet for this product and inform these patients of the possible benefits and complications associated with the use of this device".It further precautions that "the effect of pupil size on visual symptoms is not known".The dfu indicates the "smaller the optic diameter, the greater the incidence of subjective patient symptoms".Based on the complaint information and the 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; 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: 4263064
• MDR Text Key: 5028574
• Report Number: 2023826-2014-01007
• 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: Other,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/21/2014

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: 03/26/2015
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• 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