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

Model Number	VICM5_13.2
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -4.50 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The surgeon reports there is excessive vaulting and refractive surprise.Lens remains implanted.Problem is not resolved.
Additional Manufacturer Narrative
H6 - medical device problem code - 1494: off-label use (acd < 3.0mm), keratoconus.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: h6-health effect- impact code: "4627" should be added.H6- health effect- clinical code: "4581- significant reduction of iridocorneal angles" should be added.H6 - medical device problem code: "4614" should be removed and "2993" should be added.B5- the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -4.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vault, refractive surprise and significant reduction of iridocorneal angles.On (b)(6) 2023 the lens was explanted and replaced with the shorter length lens and the problem was resolved.The reporter indicated the cause of the event is other.Claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.Dimensional and functional inspection found the lens to be within specifications.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- health effect- impact code: "4627" should be removed and "4629" should be added.D6b.- "(b)(6) 2023" should be corrected to "(b)(6) 2023".B5- the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -4.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vault, refractive surprise and significant reduction of iridocorneal angles.On (b)(6) 2023 the lens was exchanged with the shorter length lens and the problem was resolved.The cause of the event is other.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -4.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vault, refractive surprise and loss of visual acuity.The lens remains implanted.The problem was not resolved.Additional information provided: "patient's post-op refraction on (b)(6) 2023: plano -3.752 x 025 w/ vault of 1070".Claim#: (b)(4).
Additional Manufacturer Narrative
B5- "the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -4.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vault, refractive surprise and loss of visual acuity.The lens remains implanted.The problem was not resolved.Additional information provided: "patient's post-op refraction on (b)(6) 2023: plano -3.752 x 025 w/ vault of 1070"".H6-health effect - impact code: "2199" should be removed and "4614" should be added.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
• MDR Report Key: 17194710
• Report Number: 2023826-2023-02531
• Device Sequence Number: 5869151
• Product Code: MTA
• UDI-Device Identifier: 00841542119306
• UDI-Public: 00841542119306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: VICM5_13.2
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 08/21/2023; 08/25/2023; 08/30/2023; 12/22/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/21/2023; 08/29/2023; 08/31/2023; 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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: INJECTOR MODEL-LIOLI-24, LOT#-UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male