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

Model Number DIB00

Device Problems Break (1069); Inaccurate Delivery (2339)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

A2 - age/date of birth: the exact date of birth is unknown, but the age 81 was provided.Section a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.D6a - implant date: not applicable, as the lens was not implanted.D6b - explant date: not applicable, as the lens was not implanted.E1: initial reporter first name: unknown, as information was asked but it was not provided.E1: email address: unknown/not provided, as information was asked but it was not provided.E1 - telephone number: (b)(6).H3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was defective during injection.The iol came out of the inserter without any pause and the back up lens was used instead.We have learned through follow up that the lens did not fall into the patient's eye but was damaged and the device was in contact with the patient's eye.No further details were provided.

Manufacturer Narrative

Section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: aug 26, 2024 section h3 - device evaluated by manufacturer? yes section h4 : device manufacturer date : mar 14, 2023 device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection revealed that the complaint device was received with the plunger rod partially advanced.Viscoelastic residue was distributed through the length of the cartridge; no cartridge damage was identified.The lens module was inspected, presenting with no damage or viscoelastic residue.Device assembly was inspected and no issues were identified.Plunger rod advancement was inspected and no issues were identified.The lens was removed from the patient card, presenting with cosmetic issue/scratches to the optic body.The complaint issues "lens damaged" and "uncontrolled delivery" were not identified during product evaluation.The observed "cosmetic issues" is similar to the reported complaint issue "lens damaged" as per coding definitions.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 17221228
• MDR Text Key: 318052441
• Report Number: 3012236936-2023-01482
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655478
• UDI-Public: (01)05050474655478(17)260314
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2024

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: DIB00I0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 09/19/2024
• Supplement Dates FDA Received: 09/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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: 81 YR
• Patient Sex: Female