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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information-unk.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -9.0 diopter, into the patient's left (os) eye.The surgeon reports the lens "vaulted too much" and high pressure.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage to the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
B1-corrected b5-additional information: on (b)(6) 2021 the lens was explanted.Additional symptoms reported: transient loss of bcva, pupil block, pigment dispersion, unreactive (fixed) pupil.The cause of the event is reported as device and unknown: "possible failure of pi's." h6-clinical code 4581 [pigment dispersion, unreactive (fixed) pupil].Health impact code corrected.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: 11558798
• Report Number: 2023826-2021-00703
• Device Sequence Number: 4767129
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/25/2021; 05/25/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/20/2021; 05/27/2021
• 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#-1495753; FOAM TIP PLUNGER MODEL-FTP, LOT#-1471717; INJECTOR MODEL-MSI-PF, LOT#-1488526
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR