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

Model Number	TMICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6, -10.50/1.0/073 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2020.The lens was exchanged with a for a shorter length lens due to excessive vault on (b)6) 2021.This resolved the problem.Reportedly, "lens too big for patient's eye.Needed replacement.".
Additional Manufacturer Narrative
(b)(6) 2021.The reporter initially stated that the patient's pupil was mid-dilated but improving.They later stated that the problem was resolved.Claim # (b)(4).
Additional Manufacturer Narrative
Device evaluation: lens was returned in micro-centrifuge vial, in liquid.Visual inspection found optic and 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: 11273788
• Report Number: 2023826-2021-00236
• Device Sequence Number: 3532856
• Product Code: QCB
• UDI-Device Identifier: 00841542106917
• UDI-Public: 00841542106917
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/01/2021; 09/27/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/18/2021; 09/28/2021
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR