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

Model Number	TMICL 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -12.5/1.0/091 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2021.Intermittent eye pain is reported.The lens remains implanted.The reporter states cause was due to the device.Cause details provided by the reporter describe multiple patient related factors that potentially contribute to the intermittent eye pain.The reporter states, "this subject's symptoms are compatible with intermittent subacute angle closure glaucoma precipitated by accommodative miosis during computer work.However, there are features which argue against this diagnosis, including the absence of any signs or symptoms following pharmacologic dilation, patent pis and normal icl vault.The history of migraine and the constellation of symptoms in this subject suggests that a diagnosis of benign episodic unilateral mydriasis may also be entertained.Nevertheless, this diagnosis must only be made if intermittent angle closure is first ruled out.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
B1: corrected to: adverse event in the initial mdr.B2: required intervention to prevent permanent impairment/damage should be added to the initial mdr.B5: "reportedly, after original tmicl surgery subject began experiencing eye pain, feeling of pressure, nausea, and pulsating vision with hear beat, intermittently over the past several months.Episodes would happen when reading and when in dim lighting.Subject had os tmicl replaced on (b)(6) 2023 which decreased the vault of the icl over the crystalline lens.Subject will be followed until her eye pain has been shown to be resolved." should be added to the initial mdr.H1: corrected to: serious injury in the initial mdr.H6: health effect - impact code: 2199 should be removed from the initial mdr.H6 - health effect - impact code: 4627 should be added to the initial mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
B5- it was also reported, "severity: grade 3/severe, outcome: unknown and relationship to device: unknown".H6-health effect- impact code: 4629 should be removed and "4627" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h6- health effect- clinical code: 4581- intermittent mydriasis.B5- the reporter indicated that the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens of diopter -12.5/1.0/091 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2021.The patient experienced intermittent eye pain and intermittent mydriasis.Reportedly, "after original tmicl surgery the subject began experiencing eye pain, feeling of pressure, nausea, and pulsating vision with heartbeat, intermittently over the past several months.Episodes would happen when reading and when in dim lighting".It was also reported, "severity: grade 3/severe, outcome: unknown and relationship to device: unknown".On (b)(6) 2023 the lens was explanted and later replaced with a different model, shorter length lens but the problem was not resolved.Additional information provided: " "(b)(6) 2022 subject complained of intermittent episodes over the past several weeks of "feeling eye pressure" os with accompanying ocular pain, hazy vision, occasional nausea and a larger pupil than fellow eye.Uncorrected visual acuity measured 20/20 and intraocular pressure was 14 mmhg, and the remainder of the examination was unremarkable.This adverse event was noted as resolved 06apr2022.On (b)(6) 2022 the subject presented for an unscheduled visit reporting eye pain which started (b)(6) 2022.Visual acuity measured 20/16, intraocular pressure was 16 and lens vault measured 616 [?]m os.The tmicl lens was exchanged on (b)(6) 2023 for vticm5 12.1, -12.5/1.0/093 evo+ icl lens.The postoperative course was uneventful.On 03mar2023, the subject reported there had been no further episodes of pain." claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5: on (b)(6) 2023, the lens was exchanged with a different model, shorter length lens and the problem was resolved.H6: health effect- impact code: "4627" should be removed and code "4629" should be added.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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15136765
• Report Number: 2023826-2022-02524
• Device Sequence Number: 14782553
• Product Code: QCB
• UDI-Device Identifier: 00841542107198
• UDI-Public: 00841542107198
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: TMICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 03/02/2023; 05/02/2023; 06/27/2023; 10/27/2023
• Initial Report FDA Received Date: 07/30/2022
• Supplement Report FDA Received Date: 03/20/2023; 05/22/2023; 06/28/2023; 11/06/2023
• Date Device Manufactured: 06/16/2021
• 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: 36 YR
• Patient Sex: Female