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

Model Number	MICL 121
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens work order search- no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm micl 12.1 implantable collamer lens of -7.5 diopter was caught within cartridge as the doctor was advancing the lens, the lens ripped on (b)(6) 2022.There was patient contact but the lens was not implanted.A backup lens was used for the implantation in the patient.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H4- device manufacturer date in initial mdr is corrected to 16-dec-2020.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that a 12.1mm micl 12.1 implantable collamer lens of -7.5 diopter was caught within cartridge as the doctor was advancing the lens, the lens ripped on (b)(6) 2022.There was patient contact.The lens was explanted on the same day, unknown if this was done intra-operatively.A backup lens was used for the implantation in the patient.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: 14493202
• Report Number: 2023826-2022-01612
• Device Sequence Number: 17597093
• Product Code: MTA
• UDI-Device Identifier: 00841542102704
• UDI-Public: 00841542102704
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

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: 10/31/2022
• Device Model Number: MICL 121
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 08/30/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/08/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Unknown