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

Model Number	VICM5_13.7
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm vicm5_13.7 implantable collamer lens -06.00 diopter, into the patient`s eye.The lens was removed due to the lens would not fit the patients eye.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Corrected data: b1: product problem b5: the reporter indicated the surgeon inserted and removed a 13.7mm vicm5_13.7 implantable collamer lens -06.00 diopter, during the same surgery due to excessive vaulting.The lens was replaced with a shorter length lens and the problem was resolved.H1: malfunction h6: health effect - impact code (f): 2199 h6: medical device problem code (a): 3189 claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h3: device evaluation: the lens was returned dry, and was returned loose in the lens box.Visual inspection found a haptic torn.There was residue and debris on the lens.Dimensional verification was performed and the lens was found to be in specification.D4: primary unique device identifier (udi) #: (b)(4)"udi related data quality updates only" h4: device manufacture date: 12-nov-2022.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 ; 6263037902
• MDR Report Key: 19671248
• Report Number: 2023826-2024-02941
• Device Sequence Number: 6964760
• Product Code: MTA
• UDI-Device Identifier: 00841542119566
• UDI-Public: (01)00841542119566(11)221112(17)241031(21)S1735260
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 10/31/2024
• Device Model Number: VICM5_13.7
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 10/23/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/08/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2022
• 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 Age: 37 YR
• Patient Sex: Male