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

Model Number VICM5_12.6

Device Problems Packaging Problem (3007); Inaccurate Information (4051)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Date of event: unk.The product is manufactured in the us, but not marketed in the us.Lens work order search: one similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the for a packaged 12.6mm vicm5_12.6 implantable collamer lens, diopter -8.5, the package was labeled with a different serial number than the patient labels included inside the box.Note-both serial numbers were within the same work order, same model, size, and power.Reportedly, the lens was not implanted.

Manufacturer Narrative

Device code 3007 should have been included in initial mdr.Result code 111 should have been included in initial mdr.Claim#: (b)(4).

Manufacturer Narrative

Device evaluation: the product was returned intact.The box was not opened.Visual inspection found that the lens package was returned unopened and that the chart label serial number does not match the box serial number.(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
• MDR Report Key: 8870925
• MDR Text Key: 158206017
• Report Number: 2023826-2019-01404
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: VICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/13/2019; 10/16/2019
• Supplement Dates FDA Received: 10/03/2019; 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1