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

Model Number	MICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated a 13.2mm micl13.2 implantable collamer lens, -10.00 diopter, was torn while loading.The lens was replaced with another same model/length lens.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Sex: unk.Weight: unk.Race: unk.Ethnicity: unk.Implant date: unk.Explant date: unk.Claim # (b)(4).
Additional Manufacturer Narrative
Sex: unk.Weight: unk.Race: unk.Ethnicity: unk.Implant date: unk.Explant date: unk.Claim # (b)(4).
Event or Problem Description
The reporter indicated a 13.2mm micl13.2 implantable collamer lens, -10.00 diopter, was torn while loading.The lens was replaced with another same model/length lens.Additional information has been requested but none has been forthcoming.

• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13090629
• Report Number: 2023826-2021-04991
• Device Sequence Number: 5423104
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 06/30/2022
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2020
• 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
• Patient Age: 37 YR
• Patient Sex: Unknown