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

Model Number VICMO12.1

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Vertigo (2134); Blurred Vision (2137); Loss of Vision (2139); No Code Available (3191)

Event Date 02/21/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But is not marketed in the u.S.Device evaluated by manufacturer? no - lens not returned.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, -15.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to loss of vision and vertigo.The lens was exchanged with another same model lens with a different diopter and the problem was resolved.The patient's best-corrected visual acuity (bcva) was 20/30.

Manufacturer Narrative

(b)(4).Review of the file indicates that the lens was not implanted in accordance with the dfu requirements, acd below 3.0mm for vicl/vticl.Device evaluation: product evaluation found that the lens was returned dry in the lens container, but there was clear surgical residue/debris on product.Visual inspection found foreign material on lens surface specified as dried, discolored material.(b)(4).

Manufacturer Narrative

The reporter indicated that the surgeon implanted a 12.1 vicmo12.1 implantable collamer lens, -15.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to unexpected refractive outcome and vertigo.The lens was exchanged with another lens of the same model but different diopter and the problem was resolved.On (b)(6) 2016, patient's post-op best-corrected and uncorrected visual acuities were 20/30.Device evaluation: the device was returned dry in a lens case/vial with clear surgical residue/debris on product.Visual inspection found no visible damage to the lens.Dimensional and functional inspections found the lens to be within specifications.(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: 5816245
• MDR Text Key: 50247128
• Report Number: 2023826-2016-00976
• 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: 07/05/2016

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: 06/30/2018
• Device Model Number: VICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/23/2017; 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR