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

Model Number VTICM5_13.2

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Iritis (1940); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).Device evaluation: lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to the lens, claim#: (b)(4).

Event Description

The reporter indicated that a 13.2mm, vticm5_13.2, -7.00/3.5/164 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od).The lens was removed on the same day, different session (1 hour later).Acute iritis, anterior chamber irrigation, and intraocular injection were reported.Patient related factor was reported as cause of this event.The reporter stated "i believe the cause is patient idiosyncrasy, developed acute iritis (mechanical friction) never seen before.The patient couldn't tolerate the pain (no increase iop) and asked for immediate removal, almost 30 min after implantation."keratoconus was reported as a pre-existing condition.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Additional information was received: tobradex drops 1x5, nevanac 1mg today, and acetazolamide 250mg 1/2 tab every 6 hours, were prescribed for one week to address the inflammation.Evacuation of viscoelastic is always performed as part of the normal procedure.After explanting the lens the problem resolved, patient is doing fine.(b)(4).No similar complaint type events were reported for units within the same lot.No intraocular injection was used.(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: 8070859
• MDR Text Key: 127141417
• Report Number: 2023826-2018-01681
• 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: 10/18/2018

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: 10/31/2019
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 12/12/2018
• Supplement Dates FDA Received: 12/05/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE:SFC45, LOT# 1392534; FTP, LOT# 1388835; CARTRIDGE:SFC45, LOT# 1392534; FTP, LOT# 1388835
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR