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

Model Number	MICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Optical Problem (3001)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is not marketed in the us.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, micl12.6, -9.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2021.Significant reduction of irido-corneal angels, blurred vision, glare/haloes, and excessive vault were observed, the lens was exchanged for a shorter length lens on (b)(6) 2021 and the problem was resolved.Cause of the event is reported as patient-related factor, "unusual anatomy".Reportedly, "all looks good, much less glare in new lens per patient.".
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in vial, in liquid.Visual inspection found haptic torn.Claim# (b)(4).
Additional Manufacturer Narrative
The reporter indicated that a 12.6mm, micl12.6, -9.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2021.Significant reduction of irido-corneal angles, elevated iop, blurred vision, glare/haloes, and excessive vault were observed, the lens was exchanged for a shorter length lens on (b)(6) 2021 and the problem was resolved.Cause of the event is reported as patient-related factor, "unusual anatomy".Reportedly, "all looks good, much less glare in new lens per patient." d9- changed to (b)(6) 2021.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
• MDR Report Key: 11416096
• Report Number: 2023826-2021-00507
• Device Sequence Number: 3544765
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: 09/30/2022
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 10/12/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/05/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR