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

Model Number VICM5_13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); No Code Available (3191)

Event Date 08/24/2019

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -12.00 diopter, in the patients left eye (os), on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to patient felt bad because her visual acuity had improved too much, and had a feeling of a foreign body.The surgeon did not implant another lens.The cause of the event was unknown.

Manufacturer Narrative

Device evaluation: the lens was returned in a micro-centrifuge vial with moisture and residue on the lens.Visual inspection found haptic torn.(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: 9227507
• MDR Text Key: 163560023
• Report Number: 2023826-2019-02012
• 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: 09/25/2019

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR