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

Model Number DCB00

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Patient weight, and ethnicity and race: not applicable as there was no patient contact.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted; therefore, not explanted.Device evaluation: the product testing could not be performed as the device was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported during product handling and prior to insertion the pre-loaded intraocular lens (iol) haptic was bent/broken.There was no patient contact and the lens was not inserted.No further information is available.

Manufacturer Narrative

Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 18-jan-2023.Device evaluation: the complaint handpiece and lens were received inside of a bag.Visual inspection under magnification revealed that the complaint lens was received damage, with a portion of the lens separated from the lens in the spare tire around the haptic.The haptic was revealed to have been received stuck inside of the original handpiece and overridden by the plunger rod.The haptic was removed and cleaned as well, revealing that the haptic was damaged.Visual inspection under magnification revealed that the complaint handpiece was received with a portion of the lens stuck inside of the cartridge and overridden by the plunger rod.The handpiece was disassembled, and the assembly was inspected, no issues were observed that could cause or contribute to the observed issues could be identified.Complaint issue "haptic damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.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
• Type of Device: 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: 16066164
• MDR Text Key: 308271713
• Report Number: 3012236936-2022-03122
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1