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

Model Number VICM5_13.7

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problems Vitreous Floaters (1866); Headache (1880); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Discomfort (2330); No Code Available (3191)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.Work order search: no similar complaints were reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.7mm vicm5_13.7 implantable collamer lens, -2.00 diopter, in the patient's left eye (os) on (b)(6) 2016.The patient experienced iris distortion, discomfort, headaches, glare/haloes, blurred vision, double vision or "ghosting", "vitreous floaters", pupil remains dilated and nonresponsive, and other miscellaneous visual disturbances.The patient is not happy with the result of the implant.On (b)(6) 2017 the patient began phylocarpine drops treatment and the dr.Is monitoring the occurence.As of the date of mdr submission the lens remains implanted.

Manufacturer Narrative

Patient also experienced excessive vault, loss of bcva, and iris atrophy.(b)(6).(b)(4).

Manufacturer Narrative

Device history record (dhr) review - based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue."phylocarpine" pilocarpine.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6540585
• MDR Text Key: 74297802
• Report Number: 2023826-2017-00741
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

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: 01/31/2019
• Device Model Number: VICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided; 09/14/2017
• Supplement Dates FDA Received: 06/16/2017; 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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
• Patient Age: 32 YR