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

Model Number VICM5_13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Blurred Vision (2137); No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Unk.Expiration date unk.Na.This product is manufactured in the u.S.But not marketed in the u.S.Unk.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -12.50 diopter, in the patients left eye (os), on (b)(6) 2020.The lens had excessive vaulting, significant reduction of ica and pigment dispersion.The patient experienced eye pain, blurring of vision and nausea.The lens remains implanted.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Additional data: the lens was explanted on (b)(6) 2020.The lens was exchanged for a shorter lens and the problem was resolved.The patient does not feel headache anymore.H6 - patient code: 3191 - secondary surgical intervention, lens exchange.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

Additional information: h3- device evaluation: lens was returned in a micro centrifuge vial with moisture on the lens.Visual inspection found no visible damage.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
• MDR Report Key: 10335509
• MDR Text Key: 200768315
• Report Number: 2023826-2020-01564
• 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: 07/03/2020

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: 11/30/2022
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/11/2020; 10/20/2020
• Supplement Dates FDA Received: 09/02/2020; 03/15/2021
• 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-PF - LOT # UNK
• Patient Outcome(s): Other; Required Intervention