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

Catalog Number DIB00VI215

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Red Eye(s) (2038); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity: information unknown/not provided.Explant date (2021 reports) : if explanted, give date: not applicable as lens remains implanted.(b)(6).Date rec¿d by mfr (2020 reports) : this report is being filed on an international device; tecnis eyhance optiblue simplicity, model dib00v that has a similar device, tecnis simplicity tecnis eyhance iol model dcb00 which is distributed in the unites states under pma p980040.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing records and related documents for the production order of the device were reviewed and no discrepancies were found during the mrr (manufacturing record review) related to this complaint.The units were manufactured and released according to specifications.A search in complaint system revealed no additional complaints have been received for this production order number.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.

Event Description

It was reported that a patient had the cataract surgery which was completed successfully without any particular problems, but the patient complained of the eye pain later.A postoperative examination: far sight vision was 0.8; corrected far sight vision was 1.0; intraocular pressure was 17.Later, the patient started to complain of the eye pain.An examination was done: far sight vision to be 0.4; corrected far sight was 0.6; intraocular pressure was 13.Redness of the conjunctiva reported.Fibrin reaction developed on the anterior surface of the intraocular lens (iol).No abnormality detected at the fundus.Mild toxic anterior segment syndrome (tass) was found and the patient was treated with eye drops and injection into the conjunctiva to be taken a wait and see approach.About a week post-op examination showed: far sight was 0.5; corrected far sight was 0.7; intraocular pressure was 17.The fibrin reaction had disappeared.It was indicated that it is unknown if the iol attributed to the symptoms.There was no patient injury reported after the patient was treated.The lens remains implanted as of to date.No further information was provided.

Manufacturer Narrative

Additional information: additional information received indicated that the patient is japanese (1945).That the ocular viscoelastic agent used were balanced salt solution (bss), shell gun, provisk.It was stated that the bacterial species has not been confirmed, not cultivated.The account also indicated that no culture or pcr (polymerase chain reaction) was performed by them.The patient receive 1.5% cravit, 3 times a day from 3 days before the surgery.Also, linderon subconjunctival injection at the end of surgery and linderon subconjunctival injection 3 days after surgery was reported.No treatment or separate treatment plans are required in the future.The lens still remains implanted in the patient's eye, visual acuity improved, and normal post-cataract condition reported.The account confirmed that they had other surgery after this patient on the day of surgery and no other similar incidents on the same surgery day was reported.The following fields were updated accordingly based on the new information received: section a2: date of birth: (1945) section a5: race: japanese corrected data: in review, it was noted that section 'h2' was inadvertently checked in the initial mdr report which should not have as the report was not a follow up report; therefore, it has been corrected in this supplemental mdr report.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
• MDR Report Key: 12249376
• MDR Text Key: 264271401
• Report Number: 2648035-2021-08229
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474739499
• UDI-Public: (01)05050474739499(17)240316
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Catalogue Number: DIB00VI215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR