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

Model Number MICL12.6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Vision (2139)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lens implanted.

Event Description

The patient reported the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -7.0 diopter, in her right eye (od).The patient reported she had lost vision during her pregnancy and the vision has not returned.The patient is now wearing contacts.The lens remains implanted.

Manufacturer Narrative

Event problem and evaluation codes: method: (process evaluation): medical review, work order search.Results: (evaluation result): per medical review: patient completed 36 month follow-up form following icl implantation stating that she had experienced decrease in visual acuity during pregnancy so she had to wear contact lens again.No report of any secondary surgically or medically intervention performed and no report of loss of bcva.According to data clarification request, received on 11/19/2015, icl was implanted bilaterally in 2012 and the patient was last seen on (b)(6) 2013 with no noted issues (va ou:20/20).No additional information was received to date from any other doctor.It should be noted that hormones produced during pregnancy and/or breastfeeding can change eyesight so per dfu: "the visian icl is contraindicated in patients 3.Who are pregnant or nursing".A work order search found no similar complaint.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, and medical review, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5327977
• MDR Text Key: 34378436
• Report Number: 2023826-2015-01748
• 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,study
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2015

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: 05/31/2013
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2016; 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2011
• 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 Age: 27 YR