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

Model Number	VTICM5_12.1
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Hernia (2240); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 12.1mm vticm5_12.1 implantable collamer lens, -12.50/+1.5/002 (sphere/cylinder/axis), during the same surgery due to lens was injected upside down in the patients right eye (od).An iris hernia and pigment was observed.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.H6: health impact- clinical code: 4581 - iris pigment.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated the iris hernia occurred during the explantation, possibly caused by an excessive amount of viscoelastic during the procedure.Has been successfully resolved.(b)(4).
Additional Manufacturer Narrative
D4: udi#: (b)(4).Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 18287997
• Report Number: 2023826-2023-05444
• Device Sequence Number: 6668255
• Product Code: QCB
• UDI-Device Identifier: 00840311304790
• UDI-Public: 00840311304790
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM5_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 01/25/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• 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: 30 YR
• Patient Sex: Female