MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; INTRAOCULAR LENS

Model Number VICMO13.2

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

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); No Code Available (3191)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity, race: unk.Pma/510k: product is manufactured but not sold in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -12.5 diopter into the patient's right eye (od) in (b)(6) 2015.The surgeon reports pigment dispersion, red eye, and permanent eye pain since implantation.The cause of the event is reported as unknown, however the surgeon thinks the footplates of the icl seem to be low, placed on/in between zonulas or on/in the ciliary body-which could cause the pain.Reportedly, the lens remains implanted.

Manufacturer Narrative

Patient code1880: headache.Claim#: (b)(4).

Manufacturer Narrative

Per email on 2019/07/25.Od implant surgery was on "(b)(6)" or (b)(6) 2015.Claim#: (b)(4).

Manufacturer Narrative

Date of event: date is approximate.Initial operation occurred either (b)(6) 2015.After implant patient reports hypermetropia of +1 and astigmatism of 0.75.Glasses were worn and partially improved the situation.Reportedly lasik was performed in (b)(6) 2017 which improved the problem.However, in (b)(6) 2018 the right eye became worse and the patient states pain is constant especially when reading.There is also a slight burning behind the eye and a feeling of nausea on the right side, even at night.Implant date: date is approximate.Additional patient code added, 3191: no code available (secondary surgery, lasik), lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8671658
• MDR Text Key: 147089415
• Report Number: 2023826-2019-01019
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2019

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: 05/31/2018
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/18/2019; 07/25/2019; 08/16/2001
• Supplement Dates FDA Received: 07/09/2019; 07/29/2019; 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-TF, LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-TF, LOT#-UNK
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR