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

Model Number MICL13.2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Vision (2139)

Event Date 04/09/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -5.5 diopter, in her right eye (od).The patient reported the vision in her right eye has gotten worse.The facility reported the patient had viral conjunctivitis in the left eye, which was resolved and was not related to the device.The patient's va post-op was 20/30 and the prognosis is good.

Manufacturer Narrative

Method: medical review, work order search.Results: per medical review: on (b)(6) 2015 the patient completed 48 month patient follow-up form and reported that "vision has gotten worse" following icl implantation.No reported secondary surgically intervention.According to dcr, dated on (b)(6) 2015, the cause of the reported event was viral conjunctivitis not related to the device.The patient was medically treated (tobradex) and the issue resolved with good prognosis.Va was 20/30 (unknown if that was corrected or uncorrected).A work order search found no similar complaints.Conclusion: 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

Event problem and evaluation codes: conclusion code(s): (device failure related to patient condition): viral conjunctivitis.(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: 5328084
• MDR Text Key: 34379789
• Report Number: 2023826-2015-01749
• 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: 09/08/2015

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: 05/31/2012
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2016; 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2010
• 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): Required Intervention
• Patient Age: 28 YR