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

Model Number	MICL 13.2
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
Per patient email had an od implant date of "on or around (b)(6) 2017".Patient states "symptoms currently on right eye - fogginess, ripples of water effect, ghosting, halos, loss of night vision.Seeking help to refund removal of right icl lens." information received form the implanting surgeon indicated that a 13.2mm, micl13.2, -13.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.For cause of this event the surgeon reported "no adverse event surgically".Prk treatment was performed on (b)(6) 2018.The lens remains implanted.On patients last visit on (b)(6) 2019, the patients ucva was 20/20-3.Clear cornea, superior pi, clear icl was reported for status of the eye (signs/symptoms).Additonal information states, "patient c/o glare/halos since original icl implanted > at night".
Additional Manufacturer Narrative
Corrected data: device code: 2993 should be corrected to code 1401 and 3001.(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: 9247857
• Report Number: 2023826-2019-02032
• Device Sequence Number: 447057
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 03/31/2019
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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: CARTRIDGE MODEL: SFC-45 LOT # UNK.; FOAM TIP PLUNGER, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention