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

Model Number MICL 12.6

Device Problem Device remains implanted (1526)

Patient Problems Cataract, Induced (1767); Loss of Vision (2139)

Event Date 02/18/2014

Event Type  Injury  

Event Description

It was reported patient had a micl 13.6 mm implantable collamer lens implanted in the patient's left eye on (b)(6) 2012.As part of the post market study, the patient reported experiencing having lost acuity in his near vision after the surgery and have difficulty focusing without the use of contacts or glasses to balance his eyesight.Also being told by his optometrist that she can see the beginnings of cataracts.The physician's office was contacted for further information.The patient's last visit was on (b)(6) 2014.The patient is now hyperopic.Stated adverse event is related to the device.Prognosis is good.Visual acuity post-treatment bcdva 20/20.The lens remains implanted.

Manufacturer Narrative

Pt weight: unk.Explant date: na.(b)(4).Method: lens work order search.Results: a lens work order search was performed and no similar complaints were found.Conclusion: conclusion not yet available.Evaluation is in progress.(b)(4).Icl remains implanted.

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4760961
• MDR Text Key: 15321681
• Report Number: 2023826-2015-00534
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer,Health Professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/24/2015

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: 04/30/2013
• Device Model Number: MICL 12.6
• Other Device ID Number: DIOPTER -11.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2011
• 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