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

Model Number	VICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device labeling was completed.Elevated iop and pigment dispersion are identified in the labeling as known adverse events from icl implantation.The dfu adequately provides instructions for icl implantation and includes known adverse events associated with lens implantation.The dfu statements include: adverse reactions and complications due to or following surgery and implantation of any evo|evo+icl may include, but are not limited to: uveitis/iritis, iop elevation from baseline, iris pigment dispersion, secondary surgical intervention to remove the lens.Even though the causality was attributed to the device 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 not returned to date.H6- health effect- clinical code 4581: pigment dispersion.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm5 implantable collamer lens of -5.00d was implanted into the patient's left eye (os) on (b)(6) 2023.The patient underwent bilateral icl implantation on the same day.Elevated iop was noted approximately 3 mos.Post-op.Pigment dispersion and inflammation are observed on an unknown date.At patient request lens explant was performed on (b)(6) 2023 by a different surgeon who continues to monitor the iop.The patient refuses to return to the implanting surgeon.The reporter did not provide last visual acuity or ocular status as the patient is under the care of a different medical provider.Based on clinic reported pre-op wtw & acd, the surgeon implanted a shorter lens than suggested by the directions for use.In the reporter's opinion the cause of the event was due to the device.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Inflammation was noted at one month follow up on (b)(6) 2023.Elevated intraocular pressure was treated with medication.Intracameral vigamox medication was used after implanting the lens.Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 18700891
• Report Number: 2023826-2024-00568
• Device Sequence Number: 20391578
• Product Code: MTA
• UDI-Device Identifier: 00840311300501
• UDI-Public: 00840311300501
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female