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); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 - unk a5 - unk a6 - unk h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm5 12.6, -5.5 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The wrong post-operative correction for calcuation was use by surgeon by error.Lens remains implanted.Cause of the event is reported as user error.
Additional Manufacturer Narrative
Corrected data: h6-health effect- clinical code: "2137" should be added.B5- the reporter indicated the surgeon implanted a 12.6mm vicm5_12.6implantable collamer lens of diopter -5.50 into the patient's left eye (os) on (b)(6) 2023.The patient experienced a refractive surprise.Reportedly "he used the wrong parameter for calculation." on (b)(6) 2023 the lens was exchanged with the same model, longer length lens and the problem was resolved.The reporter indicated the cause of the event is user error and the device did not fail to perform as intended.Cause details: "surgeon used the wrong postoperative correction for calculations".D6b.- (b)(6) 2023 should be added.H6-health effect- impact code: "2199" should be removed and "4629" should be added.H6- medical device problem code: "1401" amd "2993" 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18048073
• Report Number: 2023826-2023-04718
• Device Sequence Number: 17999042
• Product Code: MTA
• UDI-Device Identifier: 00840311300518
• UDI-Public: 00840311300518
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 04/30/2026
• Device Model Number: VICM5 12.6
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female