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

Model Number VTICM5_12.6

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

Patient Problem Endophthalmitis (1835)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.Endophthalmitis is identified in the labeling as a potential adverse event following icl implantation.Per the directions for use complications and adverse reactions implantation of any evo|evo+ icl may include but are not limited to: intraocular infection and secondary surgical intervention to remove/replace the lens.The dfu states a caution: staar surgical evo|evo+ ticl and disposable accessories are packaged and sterilized for single use only.Cleaning, reuse and/or resterilization are not applicable to these devices.If one of these devices were reused after cleaning and/or resterilization, 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.The lens was explanted and returned.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vticm5 implantable collamer lens of -10.50/+1.50/100 power was implanted into the patients left eye (os) on (b)(6) 2024.Postop ciproxacino and maxidex drops were given.On (b)(6) 2024 the lens was explanted due to observation of endophthalmitis.Anterior chamber wash and intravitreal corticosteroid/antibiotic treatment occurred.Oral antibiotics were also given.Diagnostic cultures were performed with lab results negative for organisms.There is no report of loss of visual acuity.On (b)(6) 2024 it was reported the patient has a suture in place and was doing well.The patient will undergo icl reimplantation two months later.

• 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
• MDR Report Key: 18984029
• MDR Text Key: 338659013
• Report Number: 2023826-2024-01347
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311308118
• UDI-Public: 00840311308118
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

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 Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2023
• 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
• Treatment: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female