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

Model Number	VICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uveitis (2122)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: the device remains implanted; therefore, a product evaluation cannot be performed.A review of the device labeling was completed.Elevated iop and inflammation are identified in the labeling as potential adverse events following icl implantation.Dfu precaution states: the safety and effectiveness of the icl lens has not been established in patients with 8.History or clinical signs of iritis/uveitis.The evo|evo+ clinical trial identified elevated iop can occur either at po visit 0 (1 - 6 hours) due to retained ovd or 6 to 31 days postoperative due to steroid response.Per evo|evo+ dfu warning (3) implantation of the icl lens is associated with an elevated risk of early postoperative increase in iop.With the evo icl this is usually associated with incomplete removal of the ovd.Iop should be checked 1 - 6 hours postoperatively, so an increased iop can receive treatment as quickly as possible.Warning (8) complete removal of viscoelastic from the eye after completion of the surgical procedure is essential.Staar surgical recommends a low molecular weight 2% hydroxypropyl methylcellulose or dispersive, low viscosity ophthalmic viscosurgical device (ovd).Short chain sodium hyaluronate acids are not recommended due to potential of trapped viscoelastic.A post-op inflammatory response is common after intraocular surgery which is usually mild and does not require interventions beyond the standard post-op regimen.In cases with more severe inflammation, surgical technique, intraop trauma or use of pro-inflammatory substances in the eye can be contributing factors.An exact cause could not be determined as the event could be multifactorial in nature including but not limited to pre-existing conditions and other patient and/or procedure related factors.Claim #(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5 -8.50d implantable collamer lens into the patient's right eye (od) on (b)(6) 2024 as the exchange lens to correct low vault upon implantation of a shorter lens length (12.6mm) not suggested by ocos.It should be noted, lens exchange occurred same day as initial lens implantation.Information of ovd type was not provided.Follow up on day 6 showed bcva 20/15 (better than pre-op), elevated iop of 28mmhg and uveitis.Post-op drop regimen and management details were not provided.The lens remains implanted and the patient continues to be monitored.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
H3 - device evaluation (b)(4) - device history record (dhr) review - the device history records 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.Corrective and/or preventive actions are being addressed through capa-24-001 and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.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 ; 6263037902
• MDR Report Key: 19352398
• Report Number: 2023826-2024-02205
• Device Sequence Number: 17995297
• Product Code: MTA
• UDI-Device Identifier: 00840311300570
• UDI-Public: 00840311300570
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 09/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male