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

Model Number	MICL
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -6.0 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.Excessive vault, pupil block, angle closure with elevated iop (43mmhg), glare/haloes and blurred vision was observed.Additional surgical intervention (pi) was performed.It was reported that the problem resolved, last visit date (b)(6) 2020 (bcva:20/20, ucva:20/25-, vault:1.0 ct, iop:14mmhg).The reporter stated "he developed a steroid response with corneal edema (b)(6) 2020 and was switched to lotemax from prednisolone acetate 1%.Has since been tapered off all steroids and iop lowering medications successfully." in the reporters opinion the cause of this event may have been retained ovd behind the iol.
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - angle closure, should have been specified in initial medwatch report.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: 11234650
• Report Number: 2023826-2021-00225
• Device Sequence Number: 11793583
• Product Code: MTA
• UDI-Device Identifier: 00841542103213
• UDI-Public: 00841542103213
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 12/31/2021
• Device Model Number: MICL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR