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

Model Number	TMICL13.2
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -16.0/+2.0/089 (sphere/cylinder/axis), into the patient's eye on (b)(6) 2020.Reportedly, the lens kept rotating and was explanted on (b)(6) 2020.It was not replaced due to patient anatomy.
Additional Manufacturer Narrative
B5-additional information: apparently this occurred due to the patient's anatomy.During the surgery the patient's eye wouldn't adhere to the drops in order to place the icl into the patient's eye.Claim# (b)(4).
Additional Manufacturer Narrative
B5-additional information: the lens was implanted into the patient's right (od) eye.H3-device evaluation: the lens was returned in liquid in a specimen cup.Visual inspection found that the haptic was torn.Claim# (b)(4).
Additional Manufacturer Narrative
B5-additional information: reportedly, the original lens was dislocated.After repositioning on (b)(6) 2020 the lens was replaced with a longer lens.See mfr file# (b)(4), for replacement lens.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: 11159271
• Report Number: 2023826-2021-00115
• Device Sequence Number: 13662262
• Product Code: QCB
• UDI-Device Identifier: 00841542109871
• UDI-Public: 00841542109871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/22/2020

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: 09/30/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 02/23/2021; 03/22/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/08/2021; 03/17/2021; 04/12/2021
• 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
• Patient Age: 36 YR