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

Model Number DIB00

Device Problems Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670); Scratched Material (3020); Material Split, Cut or Torn (4008); Ejection Problem (4009)

Patient Problems Corneal Edema (1791); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported as the scrub nurses noticed some resistance when the intraocular lens (iol) was primed and similarly, there was resistance as the doctor was injecting the iol into the patient's right eye.After injecting the iol the doctor noticed the iol had a tear at one of the optic edges and centrally had a scratch in the central optic.The lens was cut and explanted and a new iol with the same model and diopter was implanted during the same procedure.It was stated that the patient has significant cornea edema and temporal iris atrophy and trauma secondary to iol explantation.The wound had to be enlarged to remove the cut iol.Since the patient was elderly, the doctor sutured the wound as a precaution to prevent wound compromise if the patient rubbed her eye.The patient has endothelial damage from the iol explantation.The doctor is treating the patient with drops to treat corneal edema.If it does not resolve, the patient may need a corneal transplant.The doctor stated that he is following the patient once a week.The product is not available for return as the iol was cut in half during explantation from the eye.No other information was provided.

Manufacturer Narrative

Section a5: ethnicity: unknown, information was requested but not provided.Section a5: asian pacific islander.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - impact code: 4625 -incision enlargement & sutures.Section h6- health effect - clinical code 4581: no code available (incision enlarged).Attempts were made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: customer provided photographs were evaluated.The photographs displayed an implanted lens and a plunger rod tip.The edge of the lens and the optic body could were observed to be damaged but due to the quality of the photograph no further evaluation can be performed.The complaint issues dc-difficult to use, dc-delivery issue, and dc-use error could not be confirmed during product evaluation.The complaint issues dc-iol torn and dc-cosmetic issues could not be confirmed during product evaluation however the observed issue dc-lens damaged is similar however, could not be confirmed to be related to the manufacturing or design process.As per complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no product deficiency or product malfunction that could be identified.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: 18862183
• MDR Text Key: 337181632
• Report Number: 3012236936-2024-00631
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731783
• UDI-Public: (01)05050474731783(17)250611
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 71 KG