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

Model Number	TMICL13.7
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm, tmicl13.7, -7.00/4.0/018 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.Excessive vault and focal iridocorneal contact was reported.Repositioning of the lens was performed but it did not resolve the problem.The reporter stated that the surgeon plans to exchange the lens, patient is being monitor closely.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Reporter stated "the smaller toric icl fixed the overcrowding issue within the patients eye.Device code 1494: off-label use (over 45yrs of age at date of implant) explanted date in previous mdr corrected to (b)(6) 2019.Claim#: (b)(4).
Additional Manufacturer Narrative
Device evaluation: lens was returned in a ziploc biohazard bag.Visual inspecton found no visible damage.Claim#: (b)(4).
Additional Manufacturer Narrative
"the reporter stated that a the surgeon plans to exchange the lens, patient is being monitored closely." should be corrected to "on (b)(6) 2019 the lens was exchanged for a shorter length lens.This resolved the problem." in the initial mdr.Explant date: (b)(6) 2019.Patient code 3191: secondary surgical intervention; exchange.(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
• MDR Report Key: 8902525
• Report Number: 2023826-2019-01476
• Device Sequence Number: 16197193
• Product Code: QCB
• UDI-Device Identifier: 00841542110822
• UDI-Public: 00841542110822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/18/2019

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: 06/30/2021
• Device Model Number: TMICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 10/24/2019; 11/12/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 10/18/2019; 10/31/2019; 11/25/2019
• 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 # 1430617; FOAM TIP PLUNGER, LOT # 144211; INJECTOR MODEL: MSI-PF, LOT # UNK; CARTRIDGE MODEL: SFC-45, LOT # 1430617; FOAM TIP PLUNGER, LOT # 144211; INJECTOR MODEL: MSI-PF, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR