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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Contamination (1120); Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section h3: 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 a preloaded monofocal lens had an issue noticed on the iol after implantation.The lens was removed and replaced during the same surgical procedure with another identical model of the johnson & johnson (j&j) intraocular lens (iol).The patient fully recovered and there were no unplanned incisions, sutures, or vitrectomy involved.No further information is available.
Additional Manufacturer Narrative
In reviewing the initial mdr 3012236936-2025-0000138, it was noticed that the following "device codes" were inadvertently not included; therefore, it is captured in this supplemental report.Section h-3: device code(s): 2975 - manufacturing, packaging or shipping problem.Section h-3: device code(s): 1421 - delivered as unsterile product.Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: feb 03,2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the plunger rod fully advanced with viscoelastic residue observed distributed through the length of the cartridge.The lens module was inspected and presented with no viscoelastic residue or damage.The device assembly and plunger rod advancement were inspected and presented with no issues.The lens was attempted to be evaluated but was received folded between tape which could not be separated to remove the lens.The lens was evaluated through the translucent tape.The lens appeared to be damaged, but the nature of the damage could not be determined through the tape.No further evaluation could be performed.The complaint issue 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.Therefore, there is no indication of a product deficiency or product malfunction.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Based on additional information received.The following section have been added to reflect the new information: the surgeon observed something on the iol after implantation, possibly a scratch or fiber.The procedure was completed with another iol of the same model (j&j).No injury occurred, and no intervention was required.No patient injury, no additional complications.Section a2: age at time of the event: 40years.Section a2: date of birth: (b)(6) 1985.Section a3: gender: female.Section a4: patient weight: 103 lbs.Section a5: race : white.Section a6: ethnicity: hispanic.Section h6: device code(s): 3020 - scratched material.Section h6: device code(s): 1120 - contamination.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: 21203555
• Report Number: 3012236936-2025-000013
• Device Sequence Number: 11748022
• Product Code: HQL
• UDI-Device Identifier: 05050474731691
• UDI-Public: (01)05050474731691(17)270702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

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: DIB00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/07/2025; 08/29/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/04/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Hispanic
• Patient Race: White