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

Model Number VICMO13.2

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -10.5 diopter, into the patient's left eye (os) on (b)(6) 2020.Intraoperatively the lens was exchanged with a shorter lens due to excessive vault.The problem was resolved.The cause of the event is reported as unknown.

Manufacturer Narrative

Additional information: h3- device evaluation: lens was returned in a micro centrifuge vial with moisture on the lens.Visual inspection found the haptic torn.Claim# (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
• MDR Report Key: 10457335
• MDR Text Key: 204543069
• Report Number: 2023826-2020-01891
• 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
• Report Date: 08/04/2020

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: 07/31/2022
• 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: 08/04/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR