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

Model Number	VICM5_13.7
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm vicm5_13.7 implantable collamer lens, -10.50 diopter, into the patients right eye (od) on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due to excessive vaulting, significant reduction of irido-corneal angles and blurred vision.The lens was replaced with a shorter lens and the problem was resolved.Medication was administered.The lens was discarded.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5: there was high pressure, zonular instability, iris prolapse, iris atrophy and shallowing of ac.H6: health impact- clinical code: 4581 - zonular instability, iris prolapse, iris atophy, shallowing of a/c.H6: health effect impact code: 4644 - topical and oral anti-ocular hypertensive medication.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15195867
• Report Number: 2023826-2022-02598
• Device Sequence Number: 17528406
• Product Code: MTA
• UDI-Device Identifier: 00841542119658
• UDI-Public: 00841542119658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/13/2022

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: 03/31/2024
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male