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

Model Number	MICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2021
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.Claim#: (b)(4).
Event or Problem Description
The reporter stated that a 13.2mm,micl13.2, -13.00 diopter, implantable collamer lens was explanted.Patient had a pupillary block.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5-the reporter indicate that a 13.2mm, micl13.2, -13.0 diopter, implantable collamer lens was implanted into the patients right eye on (b)(6) 2021.On (b)(6) 2021 the lens was exchange for a shorter length lens due to pupil block with elevated iop.This exchange resolved the problem resolved.Cause of event was unknown.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - patient also experienced unreactive (fixed) pupil - should have been included.H6 - code 4628 should be corrected to 4629.H6 - health effect clinical code: 4581- unreactive fixed pupil should have been included.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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12321641
• Report Number: 2023826-2021-03143
• Device Sequence Number: 2754528
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: 00841542103350
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

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: 06/30/2021
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 02/09/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 02/08/2022; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male