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

Model Number VICM5 13.2

Device Problems Misfocusing (1401); Material Opacification (1426); No Apparent Adverse Event (3189)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.One similar complaint type events were reported for units within the same lot.Device history record (dhr) review; based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicm5 13.2, -04.50 diopter, implantable collamer lens into the patient's eye.White accretion on the lens and lens opacity were observed.Rinderon eye drops initially.Current treatment fluorometholone eye drops (patient is an athlete, cannot use steroids for long).The lens remains implanted.Per the reporter on patient's (b)(6) 2019 visit, "blurred vision has been generated from three weeks before this day.".

Manufacturer Narrative

Result code: 213 should be corrected to 114, as it is not applicable.Device code: 1401 should have been included.Patient code 3191: no code available (patient was treated with medications, rinderon and fluoromethlone) should have been included.Claim#: (b)(4).

Manufacturer Narrative

Device code: 3189 should be corrected to 1426.Adverse event should have been selected in initial medwatch report.Required intervention to prevent permanent impairment/damage (devices) should have been selected in initial medwatch report.At a follow up visit it was reported that the "white accretions of the patient's got smaller without specific medical treatment.Doctor thinks the risk of recurrence will be low.Reported lens opacity means that icl lens opacity was due to white accretions and not patient's cataract." 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: 8965322
• MDR Text Key: 156619591
• Report Number: 2023826-2019-01611
• 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: 08/08/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 10/07/2019; 11/18/2019
• Supplement Dates FDA Received: 11/05/2019; 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK; CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR