MAUDE Adverse Event Report: STAAR SURGICAL COMPANY 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

(b)(4).Device remains implanted.

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicm5 13.2 implantable collamer lens, -9.00 diopter, into the patient's left eye (os) on (b)(6) 2016.On (b)(6) 2017, the patient experienced pigment dispersion, headches, and ocular pressure.As of the date of mdr submission, the lens remains implanted in the patient and therefore, has not been returned for evaluation.

Manufacturer Narrative

(b)(4).

• Brand Name: 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: 6373025
• MDR Text Key: 68833523
• Report Number: 2023826-2017-00299
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/02/2017
• 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; Required Intervention
• Patient Age: 37 YR