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

Model Number MICL12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Edema (1791); Prolapse (2475); No Code Available (3191)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation - visual inspection of the returned product found a tear/cut from one haptic through the lens optic.The lens was returned in liquid.(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).

Event Description

The reporter stated the surgeon inserted and removed a 12.6mm micl12.6 implantable collamer lens, -8.5 diopter, during the same surgery due to the lens started to vault and was too long.The chamber was shallow and the iris had begun to prolapse through the incision.The lens was removed with no patient complications.There was iris atrophy and some corneal edema.The lens was not exchanged for another lens.After a week, the patient had improved and va was 20/25.The reporter stated the event was due to a sizing issue.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: 6462705
• MDR Text Key: 71824249
• Report Number: 2023826-2017-00551
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542102995
• UDI-Public: (01)00841542102995(17)180930
• 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: Physician
• Type of Report: Initial
• Report Date: 03/16/2017

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: 09/30/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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: 42 YR