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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the johnson and johnson (jnj) preloaded intraocular lens (iol) was defective.No further information was provided.
Additional Manufacturer Narrative
Section a, patient information: a2, a4, a5: information unknown/asku.Section b3 date of event: the exact date is unknown.The best estimate is prior to july 19, 2023, when johnson and johnson became aware of the event.Section d6a, if implanted, give date: not applicable.There's no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There's no indication the lens was implanted.Hence, 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.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the johnson and johnson(jnj) preloaded intraocular lens (iol) would not advance further down the channel.Through follow-up the doctor explained the surgical scrub placed balanced salt solution (bss) in the delivery area of the lens implantation device and partially advanced the lens.Then the doctor advanced the lens further down the delivery channel.As the lens advanced down the channel, it reached a point where it would not advance further, even with a much higher amount of force than is normally used.More bss was added but the implant still would not pass further down the channel.At that point, the doctor asked for the spare lens, and it was easily implanted into the eye.Further feedback from the customer confirmed the issue was not lens damaged but an advancement issue.The lens reached a point where it wouldn¿t move.The iol did not touch the eye.Only the cartridge had contact.There were no other complications.No further information was provided.
Additional Manufacturer Narrative
Based on additional information received from the customer, the information entered in section b5 of the initial report requires an update.Furthermore, based on the additional information section h6, medical device problem code must be corrected from 1069 to 2983.The following fields were updated accordingly.Section b5, describe event or problem: it was reported the johnson and johnson(jnj) preloaded intraocular lens (iol) would not advance further down the channel.Through follow-up the doctor explained the surgical scrub placed balanced salt solution (bss) in the delivery area of the lens implantation device and partially advanced the lens.Then the doctor advanced the lens further down the delivery channel.As the lens advanced down the channel, it reached a point where it would not advance further, even with a much higher amount of force than is normally used.More bss was added but the implant still would not pass further down the channel.At that point, the doctor asked for the spare lens, and it was easily implanted into the eye.Further feedback from the customer confirmed the issue was not lens damaged but an advancement issue.The lens reached a point where it wouldn¿t move.The iol did not touch the eye.Only the cartridge had contact.There were no other complications.No further information was provided.Section h6, medical device problem code: 2983 mechanical jam.No further information will be provided under manufacturer report number 3012236936-2023-01911.

• 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: 17386147
• Report Number: 3012236936-2023-01911
• Device Sequence Number: 6182686
• Product Code: HQL
• UDI-Device Identifier: 05050474731707
• UDI-Public: (01)05050474731707(17)260608
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 08/15/2023

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 Expiration Date: 06/08/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0175
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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 Sex: Unknown