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

Model Number DCB00

Device Problems Failure to Advance (2524); Operating System Becomes Nonfunctional (2996); Scratched Material (3020)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

It was reported that a scratch was seen on the preloaded intraocular lens (iol) and the plunger was misaligned.Account indicated that the lens would not move forward while engaging the twist motion.There was no patient contact with the product.No further information was provided.

Manufacturer Narrative

Patient age, weight and ethnicity: not applicable, as there was no patient contact with the product.If implanted, give date: not applicable, no patient contact with the product.If explanted, give date: not applicable, no patient contact with the product.Initial reporter first name: unknown/not provided.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.

Manufacturer Narrative

Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: may 31, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the handpiece was received with the lens stuck inside of the cartridge at the base of the cartridge tip and with the plunger rod overriding the lens.The cartridge tip could also be observed to be bent.The handpiece was disassembled and the assembly was inspected; no assembly issues were identified that could have contribute to or caused the lens to be stuck inside of the cartridge.The complaint lens was removed from the cartridge; however, the lens came out in pieces and torn.Both haptics were observed to be torn off of the lens as well as scratches on the lens.A crease from being folded inside of the cartridge was also observed.The complaint issue (dc-cosmetic issues and dc-plunger rod issue) was identified during product evaluation, and (dc-device advancement issue) could not be confirmed.Based on the complaint investigation results the complaint issues could not be confirmed to be related to the manufacturing or design process.Conclusion: therefore, there is no indication of a product deficiency or product malfunction.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: 14492680
• MDR Text Key: 292593736
• Report Number: 3012236936-2022-01370
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)250305
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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: DCB00
• Device Catalogue Number: DCB0000195
• 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: 04/29/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2022
• 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