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

Model Number VICM 13.2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Edema (1820)

Event Date 12/14/2013

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicm 13.2 implantable collamer lens in the patient's right eye (od) on (b)(6) 2013.The lens was explanted on (b)(6) 2013 due to excessive vaulting.Subsequently, the patient experienced pupil block, with elevated intraocular pressure (iop), angle closure and corneal edema.The lens was exchanged for a shorter lens.

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-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3613651
• MDR Text Key: 4153761
• Report Number: 2023826-2014-00095
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 01/10/2014

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: 08/31/2016
• Device Model Number: VICM 13.2
• Other Device ID Number: DIOPTER -18.00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2013
• 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: 41 YR