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

Model Number	VICM5_13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: unk.A3: unk.A4: unk.A5: unk.A6: unk.B3: unk.D4: expiration date unk.D6a: unk.D6b: unk.H4: unk.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm icl implantable collamer lens, into the patients right eye (od).The lens was reported as high vaulting and remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Corrected data: b1: product problem (lens was not explanted) b5: the reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -05.00 diopter, into the patients right eye (od) on (b)(6) 2023.The lens was reported as excessive vaulting.The patient returned for post-op visit on (b)(6) 2023 and upon examination, the lens was found to have settled and no exchange was needed.The lens remained implanted.Cause of the event was due to the device.H1: malfunction (lens was not explanted).Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h6 - work order search: no similar complaint was reported for units within the same lot.Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -05.00 diopter, into the patients right eye (od) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to excessive vaulting.The lens was replaced with a shorter lens.Cause of the event was the device.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: 17302721
• Report Number: 2023826-2023-02825
• Device Sequence Number: 6685220
• Product Code: MTA
• UDI-Device Identifier: 00840311300839
• UDI-Public: 00840311300839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2023

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: 12/31/2025
• Device Model Number: VICM5_13.2
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 10/20/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/07/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female