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

Model Number MICL13.2

Device Problems Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated the surgeon inserted and removed a 13.2mm micl13.2 implantable collamer lens, -16.0 diopter, several times during the same surgery due to the lens would not unfold in the patient's eye.The lens eventually was torn and the incision was enlarged to remove the lens.The backup lens was implanted and sutures were not required.There were no additional complications and the patient is doing well.The reporter indicated the surgeon had problems folding the lens during the loading process and the event was due to surgeon/technique error.There were no issues with the lens or injection system.

Manufacturer Narrative

Visual inspection of the returned product found the lens optic torn and a piece of one haptic torn off and missing.The lens was returned in liquid.(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: 6191981
• MDR Text Key: 62906517
• Report Number: 2023826-2016-01784
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103411
• UDI-Public: (01)00841542103411(17)170630
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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: 06/30/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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 SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR