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

Model Number	MICL12.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim#: (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2021 a 12.1mm micl12.1; -11.5 diopter implantable collamer lens was implanted into the patient's right eye (od) as a replacement lens.The surgeon indicated the patient experienced shallow ac, elevated intraocular pressure and was treated with medications lidocaine, moistat and miochol along with topical pilocarpine.Patient's angles were still narrow and went on alphagan.It was also noted that "she feels good with some improvement in her vision".Postoperative report indicated patient's iop decreased to an acceptable level.Lens remains implanted.
Additional Manufacturer Narrative
Corrected data: h10: initial claim is not applicable due to claim was found to be a duplicate of mfr# 2023826-2021-03058.See mentioned mfr# for correct claim details.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: 12278129
• Report Number: 2023826-2021-03075
• Device Sequence Number: 5097924
• Product Code: MTA
• UDI-Device Identifier: 00841542102780
• UDI-Public: 00841542102780
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 07/08/2021

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: 03/31/2023
• Device Model Number: MICL12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR