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

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

Patient Problem Uveitis (2122)

Event Type  Injury  

Event Description

The reporter indicated that bilateral sequential icl surgery was performed and implantable collamer lens that was reflected in this complaint was implanted into the patient's right eye (od).The date of implantation was not provided.Concomitant products used during the procedure were: bss, intracameral vigamox, lidocaine.Examination on (b)(6) 2023 showed presentation of anterior chamber cells and iop of 19mmhg.Postoperative uveitis was reported on (b)(6) 2023.Steroid and antibiotic drops were prescribed.The patient had a pre-existing health history of asthma and covid infection.No loss of bcva was reported.The lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

A review of the device labeling was completed.Uveitis is identified in the labeling as a known adverse event following icl implantation.The dfu adequately provides instructions for icl implantation and includes a precaution: the lens should not be exposed to any solutions other than the normally used intraocular irrigating solutions (e.G.Isotonic saline, bss, viscoelastic, etc.).The dfu provides a caution: staar surgical evo/evo+icl 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.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors, given the information that patient had pre-existing history of asthma and covid infection.Claim#: (b)(4).

Manufacturer Narrative

Originally this claim was determined to be reportable, but upon further review it was determined to not meet the definition of a complaint.New information indicated that there was no complaint against the implantable collamer lens.However, the claim cannot be voided as an mdr has already been submitted.The reported requested to cancel the claim, as there was no issue with the lens/eye.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18843051
• MDR Text Key: 336959171
• Report Number: 2023826-2024-00926
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/10/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Female