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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unk.(b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -14.50/+3.0/072 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2020.The lens was explanted on (b)(6) 2021 due to ugh syndrome caused iris atrophy and continuous pigment in the anterior chamber.Removal went well without complications.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5 - the patient had a bcva of 20/20 after explant.Per email received on (b)(6) 2021, " a replacement lens has not been implanted yet, as we are still waiting for pigment/iritis to resolve." in addition the reporter also stated that high icl vault caused ugh syndrome.H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage to the lens.Claim#:(b)(4).
Additional Manufacturer Narrative
Additional data: b5: the lens was explanted due to elevated intraocular pressure (iop) and unreactive (fixed) pupil/iris.The pis were enlarged by yag on 26-feb-2021.The cause of the event was the device.Recent post-op visit found eye still with pigment in ac and fixed iris.H3: device evaluation not required.H6: health impact- clinical code: 4581 - unreactive (fixed) pupil/iris h6: health impact - additional surgery: 4625 - enlarge pis by yag corrected data: b3: 08-feb-2021.Claim # (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.H6 - type of investigation 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).

• 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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 12271368
• Report Number: 2023826-2021-03013
• Device Sequence Number: 4507389
• Product Code: QCB
• UDI-Device Identifier: 00841542109680
• UDI-Public: 00841542109680
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/12/2021

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: 04/30/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 10/21/2021; 11/17/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/01/2021; 11/04/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female