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

Model Number	TMICL12.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Codes	Cataract (1766); Blurred Vision (2137); No Code Available (3191)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 lens, -8.0/+2.5/087 (sphere/cylinder/axis) into the patient's right (od) eye on (b)(6) 2019.On (b)(6) 2020 the lens was explanted due to lens opacity psc cortical.Transient loss of bcva is also reported.Reportedly, the patient developed psc cataracts on (b)(6) 2019 that appeared to resolve by (b)(6) 2019.The cataract reappeared in (b)(6) 2019 and bcva was limited to 20/50.
Additional Manufacturer Narrative
H6 - method code 3331.Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid.Visual inspection found a circular mark on the optic.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- "the problem was resolved with s/p catatarct extraction and a pciol implantation." this statement should be included in initial mdr.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b4-date in initial mdr is corrected to (b)(6) 2020.D10- date received by manufacturer in initial mdr is corrected to 13-mar-2020.G4- date in initial mdr is corrected to (b)(6) 2020.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
• MDR Report Key: 9936253
• Report Number: 2023826-2020-00745
• Device Sequence Number: 701619
• Product Code: QCB
• UDI-Device Identifier: 00841542106597
• UDI-Public: 00841542106597
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/12/2020

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: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 05/21/2020; 07/22/2020; 08/11/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/20/2020; 06/03/2020; 07/22/2020; 08/18/2020
• 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, LOT#-1460485; FOAM TIP PLUNGER MODEL-FTP, LOT#-1456862; INJECTOR MODEL-MSI-PF, LOT#-1426559
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR