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

Model Number DCB00

Device Problems Break (1069); Failure to Fold (1255); Inaccurate Delivery (2339)

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

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

Patient weight: 83.7 kg.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon could not implant the preloaded intraocular lens (iol) in the patient's left eye because the lead/front haptic went straight in front of the lens.The surgeon tried to pull it around while loading and just couldn't get it to go.It is noted that the lead haptic was damaged/lens defect.There was patient contact.The surgeon opened another lens to implant.The issue was not due to use error.There was no patient harm and no medical or surgical intervention was required.Through follow-up, it was learned that it is unknown if the haptic was damaged, however it just would not fold."when it got pushed forward the lead haptic just went out straight." the box for the iol looked fine (no damage).The doctor just could not get it fold.The lens was partially inserted in the eye.The doctor was able to just pull it out with no additional surgical maneuvers and inserted the back-up lens.The surgery was completed successfully using a back-up lens (same model and diopter).It is unknown how the patient is doing post-operatively.No further information was provided.

Manufacturer Narrative

Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 08, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced.The cartridge tip could be observed to be deformed.The handpiece assembly was inspected and, no issues that could cause or contribute to the complaint issues.Visual inspection of the lens revealed that it was received coated in viscoelastic residue.The lens was cleaned and, lens damage in the center of the optic body as well as scratches near the edge of the optic body could be observed.No haptic damage could be identified.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.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.

• 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: 15896907
• MDR Text Key: 307888101
• Report Number: 3012236936-2022-02883
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)250729
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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: DCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White