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

Model Number VICM5 13.7

Device Problems No Apparent Adverse Event (3189); Ejection Problem (4009)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that on (b)(6) 2019 a vicm5 13.7, -07.50 diopter, implantable collamer lens "stuck in the injector" during injection into patients left eye (os).No patient contact.Replacement lens implanted on (b)(6) 2019.Reportedly "the lens was placed in the injector correctly." the lens "did not move" when the rod was pressed, "the lens was put back into position." during injection of the lens into patient's eye, the rod passed over the lens.Lens did not "move forward or touch the eye.".

Manufacturer Narrative

Concomitant medical products - injector model: msi-pf, lot# unk.Claim# (b)(4).

Manufacturer Narrative

H3 - device evaluation: the lens was returned dry in a micro-centrifuge vial.Visual inspection found the optic torn as well as the haptic torn and bent.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 91016
• MDR Report Key: 9416981
• MDR Text Key: 169261502
• Report Number: 2023826-2019-02236
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

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: 12/31/2021
• Device Model Number: VICM5 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 02/24/2020
• Supplement Dates FDA Received: 01/14/2020; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Age: 29 YR