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 Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -7.0 diopter implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2022.Pigment dispersion, iris atrophy, fixed pupil with diffuse transillumination iris defects (tid) was observed, lens remains implanted.In the reporter opinion the cause of this event is unknown.It was also reported that the device did not fail to perform as intended.For cause details the reporter stated, "good surgical outcome, happy vision, vault good 560microns." it was reported that no medical or surgical intervention was necessary.For status of the eye (signs/symptoms) the reporter stated "persistent, mild dilated, fixed pupil with diffuse tid od only.Acuity good." for additional information the reporter stated "this is the second case of fixed pupil with diffuse tids.Keeping lens in place, as i don't think it is the icl.Will need to monitor iop due to pigment dispersion.I am unclear as to etiology, but think it may have to do with intracameral moxi-dex (5mg/cc moxi).However, no problems with cataract cases.Or other eyes for icls.".
Additional Manufacturer Narrative
H6- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: h1 - type of reportable event should have been selected as malfunction in previous supplemental mfr.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14310615
• Report Number: 2023826-2022-01395
• Device Sequence Number: 5313340
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: 00841542103237
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 09/22/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 09/06/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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
• Patient Age: 30 YR
• Patient Sex: Male