MAUDE Adverse Event Report: STAAR SUGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL)

Model Number	MICL 12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that 12.6mm, micl12.6, -9.5 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.The lens was explanted due to excessive vault, elevated iop (intraocuar pressure), pupil block and angle closure.Additional surgical intervention (enlargement of pi, yag) and medical intervention was also performed/ prescribed.In the reporters opinion the cause of this event was the device " too long lens".For status of the eye the reporter stated " explanted icl's cont.Iop, largely 20 + pigment from enlarging pi's." the following additional information was reported " pt.Required multiple wound burrs over many days along with max med.Therapy: lumigan, alphagan, timolol, trusopt diamox 500 bid.Now under control only lumigan.".
Additional Manufacturer Narrative
B5: the reporter indicated that 12.6mm, micl12.6,-9.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.On (b)(6) 2020 the lens was explanted due to excessive vault, pupil block, angle closure and iop.Additional surgical intervention (enlargement of pi, yag) and medical intervention (drop therapy) was also performed/prescribed.In the reporters opinion the cause of this event was the device, reporter stated " too long lens with excessive vault peripheral iridotomy occluded with iris vault." for status of the eye the reporter stated " patient feels vision has returned back to normal.Patients iop have been stable since being off drop therapy since 23 oct 2020.Will like to see iops stable for a couple months before proceeding with another icl procedure." claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: h6 - 4625 - enlargement of pi, should have been specified in previous medwatch reports for code 4625.B5 - "yag": should be removed as it was not specified what type of surgery was performed.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10787942
• Report Number: 2023826-2020-02584
• Device Sequence Number: 2909406
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 10/08/2020

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: 11/30/2021
• Device Model Number: MICL 12.6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 04/23/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/09/2021; 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR