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

Model Number VTICMO12.1

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4), (lens repositioning, lens explant, secondary surgery).(b)(4).Device not returned.

Event Description

The reporter indicated that the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens, -4.50/+6.0/003 diopter, into the patient's right eye (od) on (b)(6) 2016.On (b)(6) 2016 the lens was repositioned.On (b)(6) 2016 the lens was explanted due to low vault and rotation.

Manufacturer Narrative

Device evaluation: product evaluation found that the lens was returned dry in the lens case/vial and there was clear surgical residue debris on the product.Visual inspection found the lens haptic broken.Dimensional inspection found the lens is in specifications.Work order search: no similar complaints were reported for units within the same lot.Conclusion: the anterior endothelium chamber depth (acd) is below 3.0mm per dfu for this lens model, this lens model is contraindicated for acd below 3.0mm.Correctional data: previous explant date not applicable, on 12/05/2016 the lens was explanted due to low vault and rotation.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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: 6216619
• MDR Text Key: 63687290
• Report Number: 2023826-2016-01852
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/05/2016

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: 12/31/2018
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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: 32 YR