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

Model Number TICM120V4

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Endophthalmitis (1835); Intraocular Infection (1933); Pain (1994); Blurred Vision (2137); Loss of Vision (2139); Visual Disturbances (2140); Vitrectomy (2643); No Code Available (3191)

Event Date 03/14/2013

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review: based on the results of the investigation, it has been determined that nothing in the manufacturing of the lens could have caused the reported event.Claim # (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.0mm ticm120v4, implantable collamer lens, into the patient's right eye (od) on (b)(6) 2013.Patient states surgery was painful and the surgeon caused "surgical trauma" which led to infection and blurred vision.On (b)(6) 2013 patient's vision was "6/6" but by the next day patient was experiencing pain, "huge flashes," and yellowness in vision.On (b)(6) 2013 patient was diagnosed with pvd (posterior vitreous detachment).Patient states he was told he was having "ac reaction" and was given "medicinal" drops.On (b)(6) 2013 the patient was diagnosed with an infection in the eye.Patient was treated with antibiotic and anti-fungal medication.Both times patient tested negative for infection.On (b)(6) 2013 the lens was explanted.Lens was not sent to staar (manufacturer) for evaluation but to an alternate lab, in which one out of three pieces tested positive for fungal elements.Patient had several more surgeries, including vitrectomies, and several more medicinal treatments.Patient states that after the 1st implant (reference mdr 2023826-2017-00902) he had developed endophthalmitis and was left uninformed and untreated by his physician.Currently, patient has no vision in the right (od) eye.

Manufacturer Narrative

Device history record (dhr) review: based on the results of the investigation, it has been determined that nothing in the manufacturing of the lens could have caused the reported event.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; hauptstrasse 104; nidau, 2560 ; SZ 2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; hauptstrasse 104; nidau, 2560 ; SZ 2560
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6606098
• MDR Text Key: 76479140
• Report Number: 2023826-2017-00903
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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: 08/31/2014
• Device Model Number: TICM120V4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2011
• 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 Outcome(s): Other; Required Intervention; Disability
• Patient Age: 23 YR