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

Model Number	TMICL 13.2
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	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -6.50/-1.50/093 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault and pupil block with elevated iop.This exchange resolved the problem.
Additional Manufacturer Narrative
Corrected data: b3- date of event: (b)(6) 2019 is corrected to (b)(6) 2019.B5- the reporter indicated that a 13.2mm tmicl 13.2 implantable collamer lens of -6.50/-1.50/093 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault and pupil block with elevated iop.The exchange resolved the problem.D6- implant date: (b)(6) 2019 is corrected to (b)(6) 2019.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that a 13.2mm tmicl 13.2 implantable collamer lens of -6.50/-1.50/093 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault and pupil block with elevated iop and unreactive (fixed) pupil.The exchange resolved the problem.H6- patient code 3191- unreactive (fixed) pupil.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: 9565909
• Report Number: 2023826-2020-00062
• Device Sequence Number: 2197572
• Product Code: QCB
• UDI-Device Identifier: 00841542108539
• UDI-Public: 00841542108539
• 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: 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): 12/13/2019

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: 09/30/2020
• Device Model Number: TMICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 03/17/2020; 03/30/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/26/2020; 03/30/2020
• 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 WITH FTP, LOT # 1453405; FOAM TIP PLUNGER, LOT # 1452216; INJECTOR MODEL: MSI-PF, LOT # 1450941
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR