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

Model Number ICM125V4

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cataract, Induced (1767); Reaction (2414)

Event Date 07/05/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.5mm icm125v4 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.The lens was explanted on (b)(6) 2014 due to lens opacity, which was noted on (b)(6) 2014.The surgeon suspects toxic reaction from visco or lens.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Method: work order search, medical review.Results: a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found no visible damage to the lens.The lens was returned dry.The lens was rehydrated in bss for re-measurement.The lens length was measured and the result of the measurement was compared against the original value and the lens was found to be in specification.Medical review - toxic reactions may be due (but not limited) to: contaminated or inappropriate intraocular medication/irrigation fluids, instruments with residual toxins from sterilization, iol with residual toxic particles, etc.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.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.Conclusions: based on the complaint history, work order search, medical review, device history record review and the evaluation of the returned product, a specific root cause of the event could not be determined.(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-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3985424
• MDR Text Key: 4884373
• Report Number: 2023826-2014-00608
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

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: 04/30/2017
• Device Model Number: ICM125V4
• Other Device ID Number: DIOPTER -16.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 08/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• 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