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

Model Number VTICMO13.2

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Visual Disturbances (2140); No Code Available (3191)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Previous diopter: -805/+1.0/070; correct diopter: -8.5/+1.0/070.The lens has been returned and evaluated.Device evaluation: lens was returned dry in a small vial, with clear surgical residue/debris on the product and lens surface.Visual inspection found the haptic missing a piece.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2, diopter -805/+1.0/070 implantable collamer lens, into the patient's left eye (os) on (b)(6) 2016.On (b)(6) 2017 the lens was exchanged for a same size, similar diopter lens due to the patient experiencing low vault and ghosting (double vision).The surgeon decided to implant the lens horizontally, stating the lens optical zone had migrated downward.Although there is still low vault, the patient and surgeon are happy with the results.As of the date of mdr reporting the lens has not yet been returned.

Manufacturer Narrative

Previous diopter: -805/+1.0/070; correct diopter: -8.5/+1.0/070.The lens has been returned and evaluated.Device evaluation: lens was returned dry in a small vial, with clear surgical residue/debris on the product and lens surface.Visual inspection found the haptic missing a piece.Claim# (b)(4).

Manufacturer Narrative

(b)(4).

• 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: 6562054
• MDR Text Key: 74986944
• Report Number: 2023826-2017-00799
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 04/13/2017

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: 07/31/2019
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 06/15/2017; 08/11/2017
• Supplement Dates FDA Received: 07/12/2017; 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR