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

Model Number	TMICL13.2
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation type 4110: lens work order search-one similar complaint type event reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -12.5/+1.0/055 (sphere/cylinder/axis), into the patient's eye.Reportedly, the lens was absent of the markings on the haptics to verify the correct orientation.The lens was explanted and tore upon removal.See mfr rep# 2023826-2021-00956 for replacement lens.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
B1-corrected b5-previously stated the lens was implanted.The doctor "felt iffy about implanting it" so the back-up lens was implanted instead.H6-health impact code corrected.Claim# (b)(4).
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid in a vial.Visual inspection found that the haptic was torn.Haptic markings are noted.(b)(4).
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.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: 11654129
• Report Number: 2023826-2021-00955
• Device Sequence Number: 3449662
• Product Code: QCB
• UDI-Device Identifier: 00841542109369
• UDI-Public: 00841542109369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 05/25/2021; 09/17/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/17/2021; 09/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention