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

Model Number VTICMO12.6

Device Problems Failure to Unfold or Unwrap (1669); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6, -3.00/+1.50/x173 diopter implantable collamer lens in the patient's left eye.The lens did not fully unfold in the eye.Lens was removed and exchanged with another same lens model but smaller diopter size.No injury to the patient.This resolved the problem.

Manufacturer Narrative

Lens was returned in liquid in lens case/vial.Visual inspection found no visible damage to the lens.Unidentified foreign material was present on the lens surface.As per dfu for this lens model, implantation of this lens in an individual with an anterior chamber depth (acd) below 3.0mm is contraindicated.This patient had an acd of 2.96mm at the time of implantation.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• 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: 5632998
• MDR Text Key: 44451305
• Report Number: 2023826-2016-00541
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 04/04/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR