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

Model Number	DCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was missing a haptic which was noticed by the doctor after the iol was inserted into the patient¿s eye.He rotated the lens and decided not to remove it to see how the patient will respond.During a post-operative visit on (b)(6) 2025, the surgeon scheduled an explantation procedure.The iol was subsequently explanted and replaced with the same model and diopter.It is unknown if the patient experienced any symptoms.There were no complications such as capsule tear, vitrectomy, sutures, or incision enlargement.No further information was provided.
Additional Manufacturer Narrative
Section a3b, gender: the customer¿s response was ¿same¿ as sex.Section a4, patient weight: unknown/not provided.Section h3, device evaluated by manufacturer: 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 and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the initial report incorrectly reported section h6, health effect: impact code as 2199.This current report provides the correction below.The initial report incorrectly reported section h6, health effect: impact code as 4629.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the initial report incorrectly reported the aware date as july 02, 2025.This current report provides the correction below.Section g3, date received by manufacturer: jul 01, 2025.Additional information: device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation was required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.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: 22414714
• Report Number: 3012236936-2025-000186
• Device Sequence Number: 21248809
• Product Code: HQL
• UDI-Device Identifier: 05050474636057
• UDI-Public: (01)05050474636057(17)261214
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: DCB00
• Device Catalogue Number: DCB0000185
• Was Device Available for Evaluation?: No
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 08/15/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White