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

Model Number TMICL13.2

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity, race- unknown.No similar complaint type events reported for units within the same lot.Claim # (b)(4).

Event 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.

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).

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
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8795473
• MDR Text Key: 151199222
• Report Number: 2023826-2019-01231
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542108638
• UDI-Public: 00841542108638
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/23/2019; 09/25/2019
• Supplement Dates FDA Received: 08/07/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR