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

Model Number DIB00

Device Problems Material Fragmentation (1261); Difficult to Insert (1316)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section h3-other (81): the device has not been 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the johnson and johnson(jnj) intraocular lens (iol) was fully inserted into the patient's left eye when the haptic was noticed to have a missing section.The lens would not center.The iol was removed and replaced with a back-up lens of a different model and diopter, model za9003 22.0 diopter.There was no incision enlargement, no suture(s), no vitrectomy, no medical attention was required, and no medication (outside of standard care) was prescribed.A delay in the procedure was reported however the length of delay is unknown.Pre-operative best corrected visual acuity is 20/40 -1 and post-operative best corrected visual acuity is20/25 -1.Reportedly, the patient has fully recovered.No further information is available.

Manufacturer Narrative

This is to correct the initial submission section h6 adverse event problem.The health effect-impact code stated 2199 - no health consequences or impact.But the correct code is 4631 to capture removal and replacement.And 4632 to capture delay in treatment.Fields below are updated.The health effect-impact code: 4631 used to capture removal and replacement and 4632 to capture delay in treatment.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: this is to correct the initial submission section b5 states ¿haptic was noticed to have a missing section.¿ the haptic was not noticed to be missing a section.Consequently, section h6, medical device problem code: 1261 - material fragmentation should not have been included.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: 16763509
• MDR Text Key: 313528722
• Report Number: 3012236936-2023-00874
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731820
• UDI-Public: (01)05050474731820(17)250828
• 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,Followup
• Report Date: 11/29/2023

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: DIB00
• Device Catalogue Number: DIB00U0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 11/16/2023
• Supplement Dates FDA Received: 11/01/2023; 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White