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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 states a 13.2mm micl13.2 implantable collamer lens -5.0 diopter was implanted into the patient's eye.Reportedly the lens was vaulted and then was explanted.No patient injury is reported.
Additional Manufacturer Narrative
B5-additional info: the lens explanted and then replaced with a shorter lens on (b)(6) 2021 due to excessive vault.The problem is resolved.The cause is reported as other: "after implantation icl lens was found to be vaulted and surgeon decided to exchange lens." claim# (b)(4).
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned wrapped in gauze.There was residue/debris on the product.Visual inspection found that the haptic was torn and there was debris on the lens surface.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens -5.0 diopter into the patient's left (os) eye on (b)(6) 2021.The lens was explanted and later replaced with a shorter lens on (b)(6) 2021 due to excessive vault.This resolved the problem.H3: haptic was also bent.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12021865
• Report Number: 2023826-2021-01992
• Device Sequence Number: 4219459
• Product Code: MTA
• UDI-Device Identifier: 00841542103190
• UDI-Public: 00841542103190
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2021

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: 09/30/2022
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/24/2021; 07/13/2021; 11/24/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/15/2021; 08/04/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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, LOT#-1518548; FOAM TIP PLUNGER MODEL-FTP, LOT#-1508029; INJECTOR MODEL-MSI-PF, LOT#-1426559
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male