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

Model Number ICM120V4

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

The reporter indicated the surgeon attempted to insert a 12.0mm icm120v4 implantable collamer lens in the patient's left eye (os) but the surgeon noted a split on the lens and the lens was not inserted.The lens touched the patient's eye, there was no patient injury.The backup lens was implanted.

Manufacturer Narrative

(b)(4).Lens not returned.(b)(4).

Manufacturer Narrative

Method: work order search.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 liquid.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.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3625684
• MDR Text Key: 4134357
• Report Number: 2023826-2014-00108
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2016
• Device Model Number: ICM120V4
• Other Device ID Number: DIOPTER -10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 02/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2013
• 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: INJECTOR MODEL AND LOT NUMBER UNK; CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Age: 33 YR