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

Model Number VICMO13.2

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim# 717106.

Event Description

The reporter indicated that a 13.2mm vicmo13.2 implantable collamer lens, diopter -9.0 was implanted into the patient's left eye (os) upside down.This occurred on (b)(6) 2020.Intraoperatively, the lens was replaced with an alternate lens and the problem is resolved.Reportedly, no patient injury occurred and the cause of the event is reported as unknown.

Manufacturer Narrative

H3: device evaluation: lens was returned in a micro-centrifuge vial with moisture and residue on the lens.Visual inspection found the lens haptic torn and residue on the lens.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10491983
• MDR Text Key: 212559808
• Report Number: 2023826-2020-01968
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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: 02/28/2023
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR