MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER EMERALDAR INSERTION HANDPIECE; EMERALDAR HANDPIECE

Model Number	EMERALDAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Telephone number: (b)(6).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that doctor before the implanting of the intraocular lens (iol) and after the adequate mounting, according to the routine oriented by the manufacturer, it was observed that the second haptic of the iol suffered deformation caused by the injector piston.The iol issue was observed during handling prior to insertion, nevertheless, was fully inserted.The implant was immediately interrupted and the replacement of the iol and cartridge with equivalent units were requested and implanted normally.No other information provided.
Additional Manufacturer Narrative
Corrected data: in further review it was determined the suspect product should have been reported as the emeraldar handpiece as the plunger caused the lens damage.Therefore, this supplement will provide the product information for the handpiece, serial number (b)(6).As part of corrected data, below sections were updated: section d1: brand name: unfolder emeraldar insertion handpiece section d2: type of the device: emeraldar handpiece section d2: device product code: kyb.Section d4: model number: emeraldar section d4: catalog number: emeraldar section d4: expiration date: unknown, information not available.Section d4: serial number: (b)(6).Section d4: unique identifier (udi) number: (b)(4).Section d10: concomitant medical product: ar40e sn (b)(6) section h4: device manufacture date: 5/28/2014.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review of this event it was noted that additional information received from the surgery center revealed that there was no patient contact with the lens.It has been determined that the reported event is no longer considered reportable as there was no patient contact with the lens.Therefore, no further information will be submitted under medwatch 2648035-2021-07513.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER EMERALDAR INSERTION HANDPIECE
• Common Device Name: EMERALDAR HANDPIECE
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11631624
• Report Number: 2648035-2021-07513
• Device Sequence Number: 19087973
• Product Code: KYB
• UDI-Device Identifier: 05050474502178
• UDI-Public: (01)05050474502178(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2021

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: 09/30/2025
• Device Model Number: EMERALDAR
• Device Catalogue Number: EMERALDAR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/28/2021; 08/17/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/20/2021; 08/18/2021
• 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: AR40E SN (B)(6).