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

Model Number	VICMO 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- health effect- clinical code 4581:significant reduction of ica, angle closure,unreactive/fixed pupil, iris atrophy.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 13.2mm, vicmo13.2, -15.00 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2023.Excessive vault, transient loss of bcva, elevated iop, significant reduction of iridocorneal angles, pupil block,angle closure, unreactive (fixed) pupil and iris atrophy was reported.On (b)(6) 2023 the lens was explanted.Mild cortical lens opacity was observed on (b)(6) 2023.It was reported that a monofocal lens was implanted.It was reported that the problem resolved however, it was also reported that it did not resolve.Additional information and clarification has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
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.(b)(4).
Additional Manufacturer Narrative
B5- the reporter stated "the patient developed angle closure glaucoma with high iop, high vaulting of the icl, initially managed with oral diamox and topical hypotensives with variable reductions in iop with those medications.On (b)(6) 2023 the icl was removed as it was deemed that the diameter of the icl was too large for the patient's eye, contributing to the rise in iop.In order to facilitate removal of the icl, a limited anterior vitrectomy via a pars plana sclerotomy was required to provide adequate space and anterior chamber depth to allow for removal of the icl.Following the removal, the patient's iop returned to normal but the patient has persistent 5-6 mm mid-dilated pupil, though bscva is stable at 20/20-.The cause of the lens opacity is likely the high iop with glaukomflecken from the anterior segment configuration.The high vault resulted in angle closure and then the high iop which likely contributed to the lens opacity.Residual dilated pupil has not resolved.Cataract surgery has not been performed as the patient is till in the 20/20- range with correction".Following the explantation the patient has been under observation 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: 18509197
• Report Number: 2023826-2024-00227
• Device Sequence Number: 15485185
• Product Code: MTA
• UDI-Device Identifier: 00841542122061
• UDI-Public: 00841542122061
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2023

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: 02/28/2025
• Device Model Number: VICMO 13.2
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 06/12/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 04/13/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female