MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in four pieces in liquid in a lens case/vial and the delivery system returned in a biohazard bag with red clear surgical residue/ debris on product.Visual inspection found the optic and haptic torn and a haptic piece missing.Visual inspection found the injector looking dirty with some cracks on the plunger and finger grip.(b)(4).Work order search: no similar complaints types events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cc4204a, +19.0 diopter, intraocular lens in the patient's eye (od) on (b)(6) 2017.During the insertion, the lens tore and the injector broke.There is no patient injury and no widened incision or suture.The lens was exchanged with a back-up lens.
Additional Manufacturer Narrative
Additional data: there was patient contact with the lens, but no patient injury.The lens was intraoperatively exchanged.Another staar lens and injector was used as back-up and the patient is fine.The reporter does not know what caused the injector to break.Corrected data: it is a product problem, not adverse event.(b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7114228
• Report Number: 2023826-2017-01863
• Device Sequence Number: 16594046
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: 00841542102377
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 04/30/2019
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 12/28/2017
• 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: INJECTOR MODEL: MICROSTAAR INDIGO-P
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR