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

Model Number VICM5 13.2

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/08/2019

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.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 left eye (os).White accretion on the lens and lens opacity were observed.Treatment with rinderon eye drops.The lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4).Claim#: (b)(4).

Manufacturer Narrative

Adverse event or product problem: adverse event.Outcomes attributed to adverse event: required intervention to prevant permanent impairment/damage (devices).Type of reportable event: serious.Patient code 3191: no code available (medical treatment with rinderon eye drops).Cause of the event was reported as device causality.At a follow up update reporter stated "the white accretions of the patients got smaller now without specific medical treatment.Doctor thinks the risk of recurrence will be low.Reported lens opacity means that icl lens opacity due to white accretions, not patient's cataract".Claim#: (b)(4).

Manufacturer Narrative

Corrected data: result code: 213 should be corrected to 114.(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: 8965325
• MDR Text Key: 156622052
• Report Number: 2023826-2019-01612
• 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,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; 11/14/2019; 11/15/2019
• Supplement Dates FDA Received: 10/28/2019; 11/14/2019; 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: 37 YR