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

Model Number	DIB00
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.Section h3(no): 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the monofocal intraocular lens (iol) failed to deploy correctly.The issue was noted when inserting the lens into the patient's left eye.When the doctor tried to deploy, the haptic was not coming out correctly.The lens did come in contact with the eye but did not completely come out of the insertion device, would not deploy.It was confirmed that the lens partially inserted and was in the anterior chamber of the eye.It was mentioned that sinskey hook was used; however, sinskey hook did not come in contact with the lens, but did enter the eye.A new johnson & johnson lens of the same model and diopter was used as a replacement that deployed correctly.No medical and/or surgical interventions required and no patient injury reported.The patient was seen in office for post-op and no complications noted.It was indicated that the surgeon did not feel any resistance with the device when advancing the lens.That balanced salt solution (bss) at room temperature was used for cartridge lubrication.The bss was introduced into the cartridge, from the cartridge canopy.The dwell time was three (3) minutes and when advancing the lens, small ¼ twist is made which the surgical tech performs ¼ twist, 1st twist, then hands it to surgeon.No further information was reported.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: aug 15, 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed the plunger rod was advanced, and the plunger rod tip was damaged/bent.The lens module was inspected, presenting with no viscoelastic or damage indicating that the plunger rod tip damage occurred after delivery.Device assembly was inspected, presenting with no issues.The plunger rod advancement was inspected, and resistance was felt.The complaint issue "delivery issue" was not identified during product evaluation; however, resistance was felt during plunger rod advancement inspection.Manufacturing record review: the manufacturing records review was performed, and no process deviations or non-conformance report found as part of this manufacturing records review.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints were received for this production order number.Conclusion: as a result of the investigation, a product quality deficiency has been identified.A non-conformance was opened to investigate this issue as appropriate in accordance with standard operating procedures.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information/corrected data: upon further review of the product investigation, it was realized that an update/correction was required.This supplemental mdr report is being submitted to capture the update/correction of the product investigation.The information has been updated as indicated below: the complaint issue "delivery issue" was not identified during product evaluation.Conclusion: based on the complaint investigation results, a product deficiency or product malfunction could not be confirmed.The following codes are no longer applicable: section h6: investigation findings: 170 - manufacturing process problem identified.Section h6: investigation conclusions: 25 - cause traced to manufacturing.Additional codes added: section h6: investigation findings: 114 - operational problem identified.Section h6: investigation conclusions: 4315 - cause not established.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: 20287207
• Report Number: 3012236936-2024-000260
• Device Sequence Number: 8085953
• Product Code: HQL
• UDI-Device Identifier: 05050474731806
• UDI-Public: (01)05050474731806(17)270612
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2025

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 03/20/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/13/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White