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

Model Number VTICMO12.1

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Intraocular Pressure Increased (1937); Iritis (1940); Red Eye(s) (2038); No Code Available (3191)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens, -08.50/+1.5/059 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2018.The lens was explanted 2 weeks after the initial surgery due to possible inflammation.Elevated intraocular pressure was also reported.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

The reporter indicated the lens had low vaulting and the patient experienced elevated intraocular pressure.The patient's left eye (os) was red and he came to the hospital for diagnosis on (b)(6) 2018.The diagnosis was iritis.The patient was treated with anti-inflammation and intraocular pressure lowering meds.The lens was explanted on (b)(6) 2018.The patient's condition is stable.The cause of the event was unknown.Claim#: (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8984492
• MDR Text Key: 161050430
• Report Number: 2023826-2019-01675
• Device Sequence Number: 1
• Product Code: QCB
• 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,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

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: 06/30/2021
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 11/18/2019
• Supplement Dates FDA Received: 10/21/2019; 11/19/2019
• 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-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR