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

Model Number VICM5_13.2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Intraocular Pressure, Delayed, Uncontrolled (1936); No Code Available (3191)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.Result: work order search: one similar complaint were reported for units with in the same lot.Claim#(b)(4).Device remains implanted.

Event Description

The reporter indicated that the surgeon implanted a vicm5_13.2 implantable collamer lens, -09.00 diopter, in the patient's right eye (od) on (b)(6) 2016.On (b)(6) 2017 the patient experienced pigment dispersion, headaches, and ocular pressure.On (b)(6) 2017 it was documented that there was no free pigment in anterior chamber of the patient.The lens remains implanted.

Manufacturer Narrative

(b)(4).Intraocular pressure, delayed uncontrolled not reported.(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: 6381321
• MDR Text Key: 69172478
• Report Number: 2023826-2017-00325
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 02/06/2017

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: 03/31/2019
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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: 37 YR