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

Model Number VTICMO13.2

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Loss of Vision (2139); No Code Available (3191)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Pt.Date of birth and weight: - unk.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -9.0/+2.0/001 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to loss of best corrected visual acuity.The lens was exchanged for another same model/size lens but different diopter and the problem was resolved.The patient's post-op best-corrected visual acuity was 20/20.

Manufacturer Narrative

Additional information: patient's post-op uncorrected visual acuity was 20/20.Device evaluation: the lens was returned dry in a lens case/vial with clear surgical residue/debris on product.Visual inspection found no visible damage to the lens, but foreign material on lens surface (not possible to specify).(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: 6001950
• MDR Text Key: 56535807
• Report Number: 2023826-2016-01394
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/12/2016

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: 02/28/2019
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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: 18 YR