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

Model Number MICL12.6

Device Problems Difficult To Position (1467); Torn Material (3024)

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

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lens not returned.

Event Description

The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -10.0 diopter, in the patient's eye and the lens would not centered correctly.The lens tore upon removal.There was no patient injury and the backup lens was implanted within the same surgery.

Manufacturer Narrative

(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5724427
• MDR Text Key: 47398694
• Report Number: 2023826-2016-00814
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103022
• UDI-Public: (01)00841542103022(17)171231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

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: 12/31/2017
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: FOAM TIP PLUNGER MODEL: FTP - LOT NUMBER: UNK
• Patient Age: 36 YR