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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a micl12.6, -10.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.The surgeon, during implantation into the eye, noticed that the lens tore.The lens was explanted on the same day and a back-up lens of the same model was used.
Additional Manufacturer Narrative
Product evaluation found the lens returned dry in a lens case with clear surgical residue /debris on lens.Visual inspection found missing piece of haptic and clear and red residue on lens.(b)(4).
Additional Manufacturer Narrative
Corrected data: patient identifier: "unk" is corrected to "(b)(6)".Date of birth: (b)(6).Sex: "no information" is corrected to "female".The lens was exchanged for a similar lens on the same day; intraoperatively.Type of reportable event: it is corrected to a "malfunction" from "serious injury".(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6890301
• Report Number: 2023826-2017-01473
• Device Sequence Number: 19007739
• Product Code: MTA
• UDI-Device Identifier: 00841542103039
• UDI-Public: 00841542103039
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 11/01/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 09/29/2017; 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR