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

Model Number MICL13.2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Visual Impairment (2138)

Event Type  Injury  

Event Description

The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens into the patient's right eye (od) on (b)(6) 2014.The lens was explanted on (b)(6) 2014 due to the development of a cyst behind the iris and the patient complained of not being able to read.The lens was explanted with no patient injury and a multifocal lens was implanted.The patient is doing well and the va is 20/25.

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer? no, lens not returned.Evaluation: method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusions: based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Method: device history record review.Results: a review of the device history record was performed and nothing was found in the manufacturing, sterilization and packaging processes of this lens that was the root cause of the complaint.It is unlikely that the icl was the cause of this adverse event.Every icl undergoes a steam sterilization process.Before releasing the lens, quality department verifies the following for each icl lot: sterilization cycle parameters (time, temperature and pressure) must be met.Biological indicators used for every sterilization batch must be in accordance with specifications to demonstrate sterility.Lal testing must be in accordance with specifications to ensure that the product is free from any endotoxin.(b)(4).

Manufacturer Narrative

Method: medical review.Results: per medical review - reportedly, by hcp from the facility, the icl was explanted 3 months postoperatively to address development of a cyst behind the iris.An multifocal iol was implanted successfully at the same surgery date and va was 20/25.According to the reporter it is unknown if the cyst was present before icl implantation.It should be noted that there are two type of iris cysts: primary (arise from iris pigment epithelium or iris stroma; usually asymptomatic) and secondary (following intraocular surgery, ocular trauma or prolonged use of miotics; could enlarge and lead to complications).Given all this information it is very likely that either patient factor (pre-existing ocular condition) and/or procedure related factor (cyst as a postoperative complication) have caused the reported event.Conclusions: based on the complaint history, work order search and the medical review, a likely cause of the event is either patient factor (pre-existing ocular condition) and/or procedure related factor (cyst as a postoperative complication).(b)(4).

• Brand Name: VISIAN 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-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3907625
• MDR Text Key: 4663229
• Report Number: 2023826-2014-00510
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2014

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: 09/30/2015
• Device Model Number: MICL13.2
• Other Device ID Number: DIOPTER -11.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/16/2014; 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2013
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR