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

Model Number	VICM5 13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.7mm implantable collamer lens was implanted into the patients right (od) and patient has a vault of 1200.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Claim #: (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 13.7mm vicm5_13.7 -7.50d implantable collamer lens broke during loading on (b)(6) 2023.Lens was not implanted.No patient contact or injury.A replacement lens was implanted same date different surgery and problem was resolved.Reportedly, "od with size 13.7mm has a vaulting of 1200, the surgeon decides - after the lens has to be exchanged due to breakage during loading - also for a size reduction from 13.7 to 13.2mm.Sizing now 600 micron." the reporter did not indicate cause of event.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 13.7mm implantable collamer lens was implanted into the patients right (od) and patient has a vault of 1200.Lens remains implanted with the patient under observation.D4 - unk - no serial number reporter.H4 - unk.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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17553183
• Report Number: 2023826-2023-03527
• Device Sequence Number: 20053630
• Product Code: MTA
• UDI-Device Identifier: 00840311301218
• UDI-Public: 00840311301218
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: VICM5 13.7
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/21/2023; 01/24/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/18/2023; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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
• Patient Sex: Female