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

Model Number	MICL 12.1
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Cataract (1766); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient info:unk.Claim # (b)(4).
Event or Problem Description
The reporter stated that a 12.1mm,micl12.1, -10.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.It was reported that an icl exchanged is scheduled for the patient, cause is unknown.If additional information is received a supplemental medwatch report will be submitted.
Event or Problem Description
The reporter stated that a 12.1mm, micl12.1, -10.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.On (b)(6) 2021 the lens was exchanged for a longer length lens due to low vault and lens opacity (asc, observed: (b)(6) 2021)."anterior subcapsular cataract formation to edge of visual axis" was reported.It was reported that the doctor noticed the lens opacity was worsening and wanted to exchange icl for a different size, so it wouldn't rub on the lens.The reporter stated, "lens opacity is still present, we hope it stays stable and we don't notice any immediate changes." cause of this event was reported to be the device.Cause details "small icl." bcva was reported to be 20/70 on (b)(6) 2021.
Additional Manufacturer Narrative
H6- work order search: no similar complaints were reported for units within the same lot.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: 12222348
• Report Number: 2023826-2021-02865
• Device Sequence Number: 2840023
• Product Code: MTA
• UDI-Device Identifier: 00841542102766
• UDI-Public: 00841542102766
• 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: 2020
• 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
• Report Date (Section B): 06/23/2021

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: 02/28/2022
• Device Model Number: MICL 12.1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 10/26/2021
• 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 W/FTP, LOT# 1492563; FTP, LOT# 1495119; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR