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

Model Number	VICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: medical device problem code - 1494: off-label use (over 45yrs of age at date of implant).Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6; -3.50 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vaulting and refractive surprise.Lens remains implanted.The cause of the event was reported as unknown.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5: per email reply, "patient was seen (b)(6) 2023, evo icl nicely centered.Dryness from surgery has resolved and vision continuing to improved." claim# (b)(4).
Additional Manufacturer Narrative
B5 - lens was exchanged with a shorter length lens on (b)(6) 2023.Reportedly, "eye very dry.Started tears." dryness from surgery has resolved and vision continuiing to improved.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16787278
• Report Number: 2023826-2023-01468
• Device Sequence Number: 20257590
• Product Code: MTA
• UDI-Device Identifier: 00841542119054
• UDI-Public: 00841542119054
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/11/2023

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: 09/30/2024
• Device Model Number: VICM5_12.6
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 05/22/2023; 05/05/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/01/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female