MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during product handling and prior to insertion the pre-loaded intraocular lens (iol) haptic bent when opened and the lens popped out.There was no patient contact.No further information is available.
Additional Manufacturer Narrative
Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.The device was not returned for analysis therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Product investigation was received, and the following fields were updated accordingly: section a-2 patient date of birth: (b)(6) 1940.Section d-9: date returned to manufacturer: 10-jan-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed a lens stuck and overridden by the plunger rod in the tip of the cartridge with a haptic sticking out of the cartridge tip.The handpiece was disassembled and presented with no assembly issues.The lens was removed from the cartridge and cleaned, however it came out in pieces presenting with lens damage, a detached haptic, and haptic damage.The complaint issue could be confirmed; however, it may be attributed to handling during removal from the cartridge as well as an inadequate amount of ovd, suggested by the trace amounts of viscoelastic residue inside of the cartridge, and cannot be confirmed to be related to a manufacturing or design issue.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nc/er was found as part of this manufacturing records review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13112844
• Report Number: 3012236936-2021-00348
• Device Sequence Number: 11664048
• Product Code: HQL
• UDI-Device Identifier: 05050474636019
• UDI-Public: (01)05050474636019(17)240525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2022

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: 05/25/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown