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

Model Number	TMICL13.7
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter stated " 2 weeks post-op icl patient has complaints of halo".Per updated information the reporter stated that the patient is doing quite well, with glare that can be managed with brimonidine.Lens remians implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Expiration date: unk, no serial number reported.Date implanted: unk.Device manufacturing date: unk, no serial number reported.(b)(4).
Additional Manufacturer Narrative
B5- the reporter indicated that a 13.7mm, tmicl13.7, -6.0/1.0/102 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2021.Patient complaints of halo/glare post icl implantation.Per (b)(6) 2021 email from reported the reporter states "patient is actually doing quite well, with glare that he can manage with brimonidine".Patient-related factor and device was reported for cause of event.However, it was reported that the device did not fail to perform as intended.D4: (b)(6) 2023.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12791947
• Report Number: 2023826-2021-04321
• Device Sequence Number: 4529195
• Product Code: QCB
• UDI-Device Identifier: 00841542110624
• UDI-Public: 00841542110624
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021
• 2 Devices were Involved in the Event: 1 2

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 Model Number: TMICL13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: 27 YR
• Patient Sex: Male