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 Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned in vial, in liquid.Visual inspection found haptic torn.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, tmicl12.6, -14.00/4.0/118 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019.Pupil block, angle closure with elevated iop (40 mmhg), and excessive vault were observed.On (b)(6) 2019 the lens was removed and exchanged with a smaller length lens.Reporter noted "vault is still generous but safe." this resolved the problem.Cause of the event is reported as recommended lens too large.Per reporter, patients condition on last visit, (b)(6) 2019, bcva 20/50, "eye is safe, uninflamed, good iop, still generous vault but safe exam & iop, angles open.".
Additional Manufacturer Narrative
Sex: female should be corrected to male.Returned to manufacturer: 08-aug-2019 should be corrected to 30-jul-2019.(b)(6) 2019 should be corrected to (b)(6) 2019.(b)(4).
Additional Manufacturer Narrative
(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: 8889701
• Report Number: 2023826-2019-01418
• Device Sequence Number: 205922
• Product Code: QCB
• UDI-Device Identifier: 00841542107464
• UDI-Public: 00841542107464
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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: 06/30/2021
• 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: 07/30/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 10/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/11/2019; 10/16/2019
• 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: 22 YR