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

Catalog Number N/A

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

Patient Problem Iritis (1940)

Event Type  Injury  

Event Description

The reporter indicated that a patient elected to have a toric icl of -5.00/+3.00/087 (sphere/cylinder/axis) implanted in india in the left eye (os) in (b)(6) 2023.Reportedly, after the lens was implanted in india the patient presented with elevated iop on post-op day1 which normalized.The patient was treated for an unknown duration with a taper of topical steroids.The patient returned to the usa for follow-up care.The patient presented with persistent iritis upon examination in the us in (b)(6) 2024.No loss of bcva was reported.The lens remains implanted.Attempts to obtain additional information from the physician providing follow-up care has not been successful.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B3-fail date is december 2023.D6a-implant date is (b)(6) 2023.A review of the device labeling was completed.Iritis and iop elevation from baseline are identified in the labeling as known adverse events following icl implantation.The directions for use (dfu) states for complications and adverse reactions adverse reactions and complications due to, or following surgery and implantation of any evo/evo+ ticl may include, but are not limited to: uveitis/iritis, an iop elevation from baseline.The dfu states a caution: staar surgical evo|evo+ticl and disposable accessories are packaged and sterilized for single use only.Cleaning, refurbishing and/or resterilization are not applicable to these devices.If one of these devices were reused after cleaning, refurbishing, it is highly probable that it would be contaminated and the contamination could result in infection and/or inflammation.Iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases the degree of inflammation may be more severe.Procedural factors including surgical technique, inadvertent intra-operative trauma and the use of pro-inflammatory substances into the eye may have contributed to the event.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim# (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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18924950
• MDR Text Key: 337917782
• Report Number: 2023826-2024-01112
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2024

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 Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 03/18/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention