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

Model Number VTICMO13.7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Blurred Vision (2137); No Code Available (3191)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticmo13.7 implantable collamer lens, -6.0/+5.5/158 diopter, in the patient's right eye (od), on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to a refractive surprise.The lens was exchanged for another same model lens, vticmo13.7, -6.0/+5.5/166 diopter, and the problem was resolved.The reporter indicated the surgeon felt the lens was mislabeled.

Manufacturer Narrative

The lens was returned in liquid in a lens case/ vial.Visual inspection found no visible damage to the lens.Investigation confirmed the labelling issue.(b)(4).

Manufacturer Narrative

The reporter indicated the surgeon implanted a 13.7mm vticmo13.7 implantable collamer lens, -6.0/+5.5/158 diopter, in the patient's right eye (od) on (b)(6) 2017.The reporter stated that the patient could see "nothing with od and cannot move due to nausea with his astigmatism." the lens was explanted on (b)(6) 2017 due to refractive surprise.The lens was exchanged for another same model lens, vticmo13.7, -6.0/+5.5/166 diopter, and the problem was resolved.The reporter indicated the surgeon felt the lens was mislabeled.(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: 6867141
• MDR Text Key: 86245266
• Report Number: 2023826-2017-01464
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: VTICMO13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 11/29/2017
• Supplement Dates FDA Received: 10/26/2017; 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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: 32 YR