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

Model Number DIB00

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Implant date : if implanted, give date: not applicable, as lens was not implanted.Explant date if explanted, give date: not applicable, as lens was not implanted, hence not explanted.Device evaluation: product evaluation was performed under magnification.The complaint device presented with the lens stuck in the neck of the cartridge and an overridden plunger rod.The cartridge tip was observed to be damaged.A subject matter expert was consulted regarding the damage and concluded that the damage is consistent with a handpiece that had overridden a lens that was being advanced to the tip.The handpiece was disassembled and no assembly issues were identified.The cartridge tip could be observed to be damaged in a way consistent with a handpiece that had a lens stuck in the cartridge.The handpiece was dissembled and no assembly issues were identified.The complaint issue dc-dissatisfaction - quality/design was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.The special request to measure the dimensions of the cartridge could not be performed as the device was handled and measurements of the returned device would not reflect pre-handling state.However, it was stated by the subject matter expert that the device cartridges are manufactured with a molding process therefore it is unlikely that the unused tip deviated significantly from other cartridge tips.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Medical device problem code: 3191 (dc-dissatisfaction - quality/design).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during insertion into the patient's left eye, a preloaded lens (iol) was not used because the cartridge was too large for the incision made.There was patient contact.It was stated that another iol was used to complete the procedure.There was no other adverse events that occurred.Patient outcome was good.No other information was provided by the customer.Further information noted that product investigation revealed the cartridge tip could be observed damaged, thereby making event reportable.

Manufacturer Narrative

Corrected data: it was noted that the code "213" was inadvertently not entered in the section "h6 - investigation findings" of the initial mdr report.Therefore, the information has been captured in this supplemental mdr report and the following field was updated accordingly: section h6: investigation findings: 213 - no device problem found.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: 16542104
• MDR Text Key: 311596549
• Report Number: 3012236936-2023-00663
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731745
• UDI-Public: (01)05050474731745(17)250814
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• 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: DIB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2022
• 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
• Patient Sex: Female