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

Model Number ICM115V4

Device Problems Failure to Select Signal (1582); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/20/2012

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 11.5mm icm115v4 implantable collamer lens in the patient's right eye (od) on (b)(6) 2012.The lens was explanted on (b)(6) 2013 due to low vaulting.The lens was exchanged for a longer lens and the problem was resolved.

Manufacturer Narrative

Pt weight: unk.(b)(4).

Manufacturer Narrative

Method (other): work order search, medical review.Results (other): a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found one haptic torn.The lens was returned dry and there was evidence of clear surgical residue.Medical review - according to use fmea (failure modes and effect analysis) it has been determined that inadequate vaulting is a consequence of a wrong lens use failure mode (i.E.Improper white to white measurement, variability of the white to white measurements based upon different techniques utilized, improper sulcus to sulcus measurement (if ubm used), and patient condition, (poor correlation of white to white measurement and length of ciliary sulcus in an individual case; irregular ciliary sulcus or ciliary sulcus cyst).Conclusions (other): based on the complaint history, work order search, medical review and the evaluation of the returned product, a probable root cause of inadequate vaulting has been determined to be related to the inaccuracy of the white to white measurement or a mismatch between white to white and the sulcus to sulcus diameter.(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: 3653827
• MDR Text Key: 4316338
• Report Number: 2023826-2014-00159
• 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: 01/29/2014

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: 10/31/2014
• Device Model Number: ICM115V4
• Other Device ID Number: DIOPTER -10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 02/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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: 32 YR