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

Model Number	VICM513.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of -8.0 diopter was implanted into the patient's right eye (od) on (b)(6) 2024.On (b)(6) 2024, the lens was removed.Reportedly, "suspicion of the presence of a fungus growing on the lens surface." netdex col every 3 hours was provided.The eye is quiet.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
H6: lens was sent to an external lab for analysis.The analysis did not reveal any presence of fungi or bacteria - apparently it was an inflammatory process.B5: it is suspected that what was observed was an inflammatory response.The patient will possible receive another icl at a later date.Cause of the event is unknown.If any additional information is received, a supplemental medwatch report will be submitted.Manufacturer narrative: inflammation is identified in the labeling as a known potential adverse event following icl implantation.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Claim# (b)(4).
Additional Manufacturer Narrative
H6: device history record: dhr review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
H3: lens was returned in liquid in a specimen cup and blood collection tube.Visual inspection found an optic and haptic torn lens with residue on the piece of the lens.Lens was torn in two pieces, each piece was returned in seperate containers.Fungus/deposits were not identified.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the lens removed.Later, a shorter length lens was implanted and the problem was resolved.Claim# (b)(4).
Additional Manufacturer Narrative
D10 - corrected to unk.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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 19697765
• Report Number: 2023826-2024-02911
• Device Sequence Number: 19755705
• Product Code: MTA
• UDI-Device Identifier: 00840311300891
• UDI-Public: 00840311300891
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024

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 Model Number: VICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 09/27/2024; 09/19/2024; 09/26/2024; 03/28/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/29/2024; 10/16/2024; 10/16/2024; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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 - LOT# UNK.; FOAM TIP PLUNGER LOT# UNK.; INJECTOR MODEL: MSI-PF - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female