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

Model Number VICMO 12.1

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

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 12/24/2018

Event Type  Injury  

Manufacturer Narrative

Weight: unk, ethnicity: unk, race: unk.This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.1 mm, vicmo12.1, -7.50 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2019 the lens was exchanged for a longer length lens due to low vault.This exchange resolved the problem.

Manufacturer Narrative

Aware date in initial mdr corrected to 24-jun-2019.Date received by manufacturer should be corrected to 24-jun-2019 in initial mdr.Date received by manufacturer should be corrected to 31-jul-2019 in follow-up#1.Patient code 3191: no code available: secondary surgical intervention, lens exchange patient code 3189 in initial mdr no longer applicable.Claim#: (b)(4).

Manufacturer Narrative

Device evaluation: lens was returned in a microcetrifuge vial.Visual inspection found the haptic torn.Device code 1494: off label use - acd<3.0mm.(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: 8816889
• MDR Text Key: 151888647
• Report Number: 2023826-2019-01216
• 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: 06/24/2019

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: 05/31/2021
• Device Model Number: VICMO 12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 06/23/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 08/27/2019; 09/27/2019
• Supplement Dates FDA Received: 08/27/2019; 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45, LOT# UNK; INJECTOR MODEL: MSI-TF, LOT # UNK; CARTRIDGE MODEL: SFC-45, LOT# UNK; INJECTOR MODEL: MSI-TF, LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR