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

Model Number ICM115V4

Device Problems Inadequacy of Device Shape and/or Size (1583); Missing Value Reason (3192)

Patient Problem No Code Available (3191)

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

Diopter: -11.50.Pt weight: unk.(b)(4).Conclusions code(s): conclusion not yet available.Evaluation is in progress.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 11.5mm icm115v4 -11.00 diopter implantable collamer lens in patient's right eye on (b)(6) 2013.Low vault was noted.On (b)(6) 2015 the lens was explanted and exchanged for another, same model and diopter size.This resolved the problem.Patient's last visit on (b)(6) 2015, ucva was 20/20.

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5549342
• MDR Text Key: 41937108
• Report Number: 2023826-2016-00386
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2016

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: 12/31/2015
• Device Model Number: ICM115V4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2013
• 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 LOT NUMBER
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR