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

Model Number	VICM5 12.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm, vicm5_12.6, -3.5 diopter, implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) /2023 the lens was replaced with a same size , different diopter toric lens due to refractive surprise.The problem was resolved.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the product.Visual inspection found haptic bent.Dimensional inspection found the lens to be within specifications.Functional inspection found the lens did not meet original values measured at the time of manufacturing.H6: type of investigation 3331 - 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).
Additional Manufacturer Narrative
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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18788738
• Report Number: 2023826-2024-00751
• Device Sequence Number: 20895808
• Product Code: MTA
• UDI-Device Identifier: 00840311300471
• UDI-Public: 00840311300471
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 02/06/2024

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: 02/28/2026
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 03/31/2024; Not provided
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/20/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female