MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS

Model Number	TMICL13.2
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity, race- unknown.No similar complaint type events reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm tmicl13.2 implantable collamer lens, -7.0/+3.0/088 (sphere/cylinder/axis) into the patient's eye on (b)(6) 2019.The surgeon reports the lens "wouldn't lay flat-looked like there was a fold in it." intraoperatively, the surgeon removed the lens and successfully implanted a back-up lens.After the initial lens was removed, nothing obvious was noted on the lens.
Additional Manufacturer Narrative
"phakic intraocular lens, product code: mta" should be corrected to "phakic toric intraocular lens, product code: qcb" in the initial mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: surgery occurred in the left (os) eye.Device evaluation: the lens was returned in liquid, in a lens vial.Visual inspection found that the haptic was torn.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8795473
• Report Number: 2023826-2019-01231
• Device Sequence Number: 1978551
• Product Code: MTA
• UDI-Device Identifier: 00841542108638
• UDI-Public: 00841542108638
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 09/25/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/07/2019; 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR