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

Model Number MICL12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Detachment (2445); No Code Available (3191)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).

Event Description

The patient reported the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.0 diopter, in her right eye (od).The patient reported posterior vitreal detachment and latticing.The lens was implanted on (b)(6) 2013 and remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

The facility reported they agreed with the patient report of posterior vitreal detachment and latticing.The date of the last visit was (b)(6) 2017 and the patient's post-op visual acuity was 20/20.The facility reported the adverse event was not related to the device; no medications and/or treatments were required and there were no other health effects as a result of the ocular condition.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6789687
• MDR Text Key: 82558979
• Report Number: 2023826-2017-01302
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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: 02/28/2015
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2013
• 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: 38 YR