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

Model Number	TMICL13.2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
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
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 implanted and flipped upside down.The lens was explanted and tore upon removal.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
B5-previously stated the lens flipped upside down.Corrected info: the lens tore during injection into the patient's left (os) eye.H6-device code corrected.Claim# (b)(4).
Additional Manufacturer Narrative
B5-additional information: "flipped.Tore on removal." h3-device evaluation: the lens was returned in liquid in a vial.Visual inspection found that the haptic was torn.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 13.2mm tmicl13.2 implantable collamer lens, -12.5/+1.0/055 (sphere/cylinder/axis) tore during delivery into the patient's left eye (os).Since this lens was a back up lens, the patient had to wait two days for an alternate lens to be implanted.The problem was resolved.Claim#: (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: 11654099
• Report Number: 2023826-2021-00956
• Device Sequence Number: 17024189
• 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
• Device Implanted Year: 2021
• 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,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?: No
• 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; 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; 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: INJECTOR MODEL-MSI-PF, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention