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

Model Number	VICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm, vicm5_12.6, -6.0 diopter, implantable collamer lens was exchanged.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A1 - a6 - unk.B3 - unk.D6a - unk.D6b - unk.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - the patient had blurry vision as a result of the wrong implanted lens - should have been included in previous mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6; -06.00 diopter implantable collamer lens into the patient's eye.The surgeon exchanged the lens for a same length but different power lens.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.H10 - disregard supplemental #1 mdr as it was submitted in error with the wrong claim detail corrections.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: 17216360
• Report Number: 2023826-2023-02162
• Device Sequence Number: 15010800
• Product Code: MTA
• UDI-Device Identifier: 00841542119108
• UDI-Public: 00841542119108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2023

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: 10/31/2024
• 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: 06/03/2023
• Supplement Date Received by Manufacturer: 09/04/2023; 09/04/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 09/04/2023; 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown