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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -16.50/3.0/076 (sphere/cylinder/axis) implantable collamer lens was explanted due to sizing issues.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Implant date: unk.Explant date: unk.(b)(4).Claim#: (b)(4).
Additional Manufacturer Narrative
The reporter indicated that a 13.2mm, tmicl13.2, -16.5/+3.0/076 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to significant reduction of iridocorneal angles.For cause details the reporter stated "at the day 1 postoperative visit, the uncorrected visual acuity measured 20/32 od.Intraocular pressure was 18 mmhg od.Narrow angles ou." a replacement lens of shorter length was implanted on the same day as removal.If additional information is received a supplemental medwatch report will be submitted.H6- health effect- clinical code 4581: narrow angles.Claim # (b)(4).
Additional Manufacturer Narrative
Additional information: b5: reportedly, increased iop >= 30 mmhg or > 10 mmhg above preop iop.A replacement lens of shorter length was implanted on the same day as removal.Problem resolved.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - per email on 21 jun 2023, problem was resolved.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: "reportedly, increased iop >= 30 mmhg or > 10 mmhg above preop iop.A replacement lens of shorter length was implanted on the same day as removal.Problem resolved." should be omitted for correction.H6: 1937 should be omitted for correction.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: 14647638
• Report Number: 2023826-2022-01781
• Device Sequence Number: 14883172
• Product Code: QCB
• UDI-Device Identifier: 00841542109963
• UDI-Public: 00841542109963
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 07/05/2022; 06/21/2023; 07/07/2023; 07/25/2023
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 09/15/2022; 07/12/2023; 07/21/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2020
• 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: 36 YR
• Patient Sex: Female