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

Model Number VICM5_12.6

Device Problem Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that a packaged 12.6mm vicm5_12.6 implantable collamer lens, diopter -8.5, was possibly labeled with a different serial number than the patient labels included inside the box (reporter did not open the box).Reportedly, the lens was not implanted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluation: the lens was returned in an unopened box.The box and label serial numbers are the same.(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: 9120425
• MDR Text Key: 160191500
• Report Number: 2023826-2019-01738
• 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: 08/30/2019

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: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/16/2019; 11/27/2019
• Supplement Dates FDA Received: 10/28/2019; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1