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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative - surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim # (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation with refractive surprise.In a separate visit lens repositioning was performed but it did not resolve the problem (lens was not stable, rotated again).The lens was later exchanged for a spherical lens of the same length and the problem resolved.Residual astigmatism will be treated by prk.Cause of event was reported as unknown.There are multiple medical device reports associated with this patient.This report is 2 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined that the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
H6 device evaluation: lens was returned dry with residue/debris on product in a micro-centrifuge vial.Visual inspection found that the haptics were bent/deformed, and the optic was also deformed.Dimensional inspection found the lens to be within specifications.Functional inspection found the lens to be out of specification.Correction: g4 premarket identification: device bla: p030016 to pma/510(k): p030016, initially reported pma/510(k) number in the wrong field.(b)(4).
Additional Manufacturer Narrative
Additional data: h6- device history record (dhr) review: based on the results of the investigation, the 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).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20218605
• Report Number: 2023826-2024-04281
• Device Sequence Number: 7202774
• Product Code: QCB
• UDI-Device Identifier: 00840311308910
• UDI-Public: 00840311308910
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Report Date (Section B): 08/20/2024

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: 08/31/2026
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 12/02/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/20/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male