MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC EC-3 PAL

Model Number	003500-0020-309
Medical Device Problem Codes	Material Integrity Problem (2978); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.Additional serial number was provided and is as follows (b)(4).Udi for additional serial number: (b)(4).The lenses have yet to be returned; thus, a proper device analysis could not be completed.Distorted haptic are know to be caused by numerous factors including, but not limited to : loading strategy.Lens placement technique.Accessory device support.Poor handling during folding and inserting.The reported damages were not reported during the inspection prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.The directions for use (dfu) provide precautions for the lens handling and injection process by stating that: "improper handling of this lens may cause damage to the haptics and the optics." a review of the device history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the lens and the reported issue appears to be related to the operational context of the procedure and not a malfunction of our device.However, the use of the additional lens to correct the patient's vision is considered medical intervention to prevent permanent impairment to the patient our lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lenses was processed per standard operation procedures and inspections, and met all of the criteria for release.
Event or Problem Description
It was reported that during the attempt to implant the lens the haptic inserted at a different angle than the other one thus the lens was removed.After inserting the spare lens it was noted that the haptic was broken.Thus, this lens as well was removed.A third lens was used to successfully complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information provided.

• Brand Name: EC-3 PAL
• Common Device Name: EC-3 PAL
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s vintage ave. bld. a; ontario, ca
• MDR Report Key: 10405137
• Report Number: 3010126268-2020-00003
• Device Sequence Number: 3257044
• Product Code: HQL
• UDI-Device Identifier: 00884872025732
• UDI-Public: (01)00884872025732(17)210731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 003500-0020-309
• Device Catalogue Number: 003500-0020-309
• Device Lot Number: 3S160817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2020
• 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