MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed no additional complaint folders for this po number.No escalation was required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the preloaded intraocular lens (iol) was fully inserted in the right eye, a refractive error (myopic, residual astigmatism) was identified at post-operative visits.Pre-operative visual acuity (va) was 20/30 corrected (cc).Post-operative va was 20/40 uncorrected (sc) and 20/20- cc.The patient's daily activities were not significantly affected.The iol was explanted from the eye.There was no required incision enlargement, sutures, or vitrectomy.There was no delay in procedure.The end user did not seek medical attention and it is unknown if medication was prescribed.Through follow-up it was learned that symptoms started on (b)(6)2022.The patient had a 16-cut radial keratotomy (rk) procedure done years ago.The patient's pre-operative va was 20/30- uncorrected.The patient was approximately 1.0 d myopic with residual astigmatism.The doctor noted that the cuts from the rk make it difficult to choose a lens.This patient has been consistently near sighted, so the doctor chose a weaker power and toric lens to address the astigmatism.Another johnson and johnson iol was implanted as replacement (same model diu, different cylinder of 3.00 and different diopter of 18.5).There was no patient injury reported.The patient is doing okay post-operatively.The patient's post operative va was 20/40 -2 uncorrected at one and one-half weeks out after surgery.The patient had mild corneal edema following the iol exchange, so the surgeon would expect the patient's vision to take a little time to settle out; however, the patient subjectively feels the vision is better than before.The doctor believes that the patient¿s vision will improve with time.The surgeon plans to continue to monitor this patient.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: nov 7, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint lens was received cut into pieces (one piece missing), and a haptic was detached.The lens was cleaned and no issues that could contribute to or cause the complaint issue could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue "unexpected postop refraction" 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.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 IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15684972
• Report Number: 3012236936-2022-02698
• Device Sequence Number: 6348903
• Product Code: MJP
• UDI-Device Identifier: 05050474746534
• UDI-Public: (01)05050474746534(17)241212
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 12/04/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White