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

Model Number	TMICL13.2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 13.2mm tmicl13.2 implantable collamer lens, -15.00/+2.5/099 (sphere/cylinder/axis), within the same surgery due to the lens was inserted upside down in the patients left eye (os).There was no patient injury.The lens was replaced with another same model/length lens within the same surgery and the problem was resolved.A suture was required.The patient is doing well.The reporter indicated they felt the lens was loaded too early and caused the lens to rotate in the cartridge.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned wrapped in gauze, with moisture on lens.Visual inspection found one haptic torn.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11405330
• Report Number: 2023826-2021-00549
• Device Sequence Number: 17030397
• Product Code: QCB
• UDI-Device Identifier: 00841542109741
• UDI-Public: 00841542109741
• 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: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 02/09/2021

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: 07/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Age: 42 YR