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

Model Number VICMO12.6

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

Patient Problems Corneal Decompensation (1790); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -18.00 diopter, in the patients left eye (os), on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to angle closure, with elevated intraocular pressure (iop), corneal decompensation and retinal detachment.Phaco-emulsification (cataract surgery), iol implantation and retinal repair was performed.The problem was resolved and the retina is in place.The cause of the event was unknown.

Manufacturer Narrative

B5: the reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens -18.00 diopter in the patients left eye (os) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to retinal detachment.Phaco-emulsification (cataract surgery); iol implantation and retinal repair was performed.The problem is resolved.H6 - health effect clinical code 4581,1937,1790 is not applicable in initial mdr.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 12125559
• MDR Text Key: 264171300
• Report Number: 2023826-2021-02334
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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: 03/31/2022
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/31/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-TF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female