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

Model Number	MICL 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl 13.2, -13.0 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2021.The lens was replaced with a shorter length lens due to elevated iop(32mmhg) without pupil block and angle closure (assessed on (b)(6) 2021) and excessive vault on (b)(6) 2021.This resolved the problem.Cause of the event is reported as device, recommended length was too long.Reportedly, eye is clear, good vault, normal.Patient reported "rainbow effect in vision".

• 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: 12341302
• Report Number: 2023826-2021-03173
• Device Sequence Number: 3516337
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: 00841542103350
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/19/2021
• 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: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR