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

Model Number	TMICL13.2
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned dry ,in cartridge case.Visual inspection found residue on lens surface and a torn haptic.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
Received a damaged 13.2mm , tmicl13.2, -11.0/2.0/068 (sphere/cylinder/axis), implantable collamer lens with no reported patient injury.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data device code 2923: lens rotation.(b)(4).
Additional Manufacturer Narrative
Corrected data: event: lens repositioning was also attempted.Device code: 2923 lens rotation in previous mdr is not applicable.(b)(4).
Additional Manufacturer Narrative
The reporter indicated that a 13.2mm, tmicl13.2, -11.00/2.0/068 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.The lens was removed and replaced within the same surgery due to lens tear/break during injection/delivery into the eye.No patient injury was reported.In the reporters opinion the cause of the event was user error.It was reported that the replacement lens resolved the issue.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
• MDR Report Key: 9131632
• Report Number: 2023826-2019-01793
• Device Sequence Number: 1749543
• Product Code: QCB
• UDI-Device Identifier: 00841542109178
• UDI-Public: 00841542109178
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/28/2019

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 12/02/2019; 12/03/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/28/2019; 12/02/2019; 12/03/2019
• 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: UNK.
• Patient Age: 32 YR