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

Model Number VICM512.6

Device Problems Misfocusing (1401); No Apparent Adverse Event (3189)

Patient Problems Glaucoma (1875); Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Age: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Expiration date unk.Implant date: unk.Explant date: unk.Manufacture date: unk.(b)(4).

Event Description

The reporter indicated the surgeon implanted an icl implantable collamer lens, in the patients left eye (os).The patient reported eye problems and possible loss of vision.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional information: b5: a 12.6mm vicm512.6 implantable collamer lens of a -12.0 diopter was implanted into the patient's left eye (os) on (b)(6) 2022.Reportedly, "as soon as i woke up from anesthesia i had unbearable pain in the left eye with vomiting and nausea.It turned out that i had an attack of ocular hypertonia.The ophthalmologist put me on a mannitol infusion and gave me diamox tablets with drops to lower the ocular tension without results." on (b)(6)2022, an optical coherence tomography found, "irridocornean angle is closed (2 degrees).The lens was explanted and the reporter stated, "i had corneal edema, a loss of endothelial cells (i only have 1000 at the moment) an opacity of the lens (glaucomaflecken because of the ocular hypertension crisis) pupillary mydriasis and glaucoma with significant loss of optic nerve fibers in the eye." the right lens remains implanted and is causing chronic pain and double vision, and with the left eye damage the reporter stated, "suffering anisometropia due to the difference of vision." reportedly, "we have two hypotheses to know what happened to my left eye either the implant was bigger than my eye in this case the ophthalmologist had to change the implant immediately or it's due to obstruction of the central aquaport with viscoelastic and inflammatory debris." h6: work order search found one similar complaint - 727444 for fellow right eye (od).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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16048692
• MDR Text Key: 308081291
• Report Number: 2023826-2022-04678
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: P030016
• 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: 11/29/2022

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 Model Number: VICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/26/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2021
• 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: UNK.
• Patient Sex: Male