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

Model Number DCB00

Device Problem Difficult to Insert (1316)

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

Event Date 09/06/2023

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.Therefore, not explanted.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 the johnson and johnson(jnj) intraocular lens (iol) was not positioning correctly.The iol was fully inserted into the patient¿s operative eye.However, the iol was leaning or rubbing up against the eye.Reportedly, there didn¿t appear to be any scratch or damaged haptic or any damage to the lens.Because it was not positioning correctly the doctor removed it.A backup iol of the same model was used to complete the procedure.There were no complications such as a capsule tear, vitrectomy, incision enlargement or sutures.No further information was provided.

Manufacturer Narrative

Section d9: device available for evaluation? yes section d9: date returned to manufacturer: oct 24, 2023 section h3: evaluated by manufacturer: yes device evaluation: the complaint handpiece was received inside of the original folding carton.No iol was received.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced.The complaint cartridge was received with the cartridge tip stretched and with stress marks; however, stress marks and stretching are considered within specification for a used handpiece.Further inspection of the cartridge revealed that there was viscoelastic residue dispersed throughout the length of the cartridge, suggesting that an appropriate amount of ovd/bss was used.The lens module was inspected and, no marks that would indicate that the plunger rod advanced incorrectly could be identified.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 17866402
• MDR Text Key: 324868813
• Report Number: 3012236936-2023-02491
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)260528
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White